Pacira BioSciences jobs in San Diego, CA

About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together. Summary: This role will be responsible for the configuration, maintenance, monitoring, and troubleshooting of network systems and cloud resources. It will also be responsible for supporting the broader IT team in implementing new technologies into the company and providing support to the service desk and business units. Responsibilities Essential Duties & Responsibilities: * Manage and monitor company network components, including switches, routers, wireless, and firewalls. * Administer, monitor and maintain the Company's IT infrastructure. * Configure and troubleshoot work on various network devices. * Integrate infrastructure components into the network. * Support company storage projects and data backups. * Provide support to end-users for hardware and software issues * Assume responsibility for basic and intermediate administration of VMware environments. * Create and maintain necessary technical support documents. * Provide network/system utilization and security reports. * Assist in vulnerability assessments and reporting. * Administer and support Active Directory / Office 365. * Research and evaluate new technologies relevant to corporate initiatives Supervisory Responsibilities: This person has no direct supervisor responsibilities. Interaction: Work closely with IT management and staff, employees, external vendors, and consultants. Qualifications Education and Experience: * 3+ years experience as a Network/Systems Engineer required * Bachelor's degree in computer science/information technology from an accredited college or university preferred * Cisco certification is preferred * Proficient experience in firewall configurations * Experience in network design * Experience with Microsoft Windows Server 2016 and above * Substantial knowledge of and experience working in a Networking environment and Windows platforms * Experience with VMWare ESX Servers (7.0 and above) * Experience with VEEAM is a plus Qualifications: To perform this job successfully the role must meet the requirements listed below: Knowledge, Skills, and Abilities: * Substantial knowledge of and experience working in a Networking environment and Windows platforms. * Experience in the design, implementation, and maintenance of Cisco and Meraki platforms that meet vendor best practices. * Experience in virtualization VMWare ESX Servers (7.0 and above) * Knowledge of Dell and HPE storage solutions. * Excellent written, oral, and interpersonal English communication skills, along with excellent presentation skills. * Able to travel up to 10%. Physical Demands: While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds. Work Environment: Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. Benefits Benefits: * Medical, Prescription, Dental, Vision Coverage * Flexible Spending Account & Health Savings Account with Company match * Employee Assistance Program * Mental Health Resources * Disability Coverage * Life insurance * Critical Illness and Accident Insurance * Legal and Identity Theft Protection * Pet Insurance * Fertility and Maternity Assistance * 401(k) with company match * Flexible Time Off (FTO) and 11 paid holidays * Paid Parental Leave Pay Transparency The base pay range for this role is $102,800 to $140,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. EEO Statement EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose. Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.

Director of Quality Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. The following summary represents an ideal situation for a site with a high degree of operational excellence and a mature Quality Culture. The Site Quality Director will implement strategies and tactical objectives to move the site towards this general model over time. * 30% Global leadership: working with the BU VP Quality and the other CSS Quality Directors to create and implement Business Unit quality strategy, global quality policies, BU quality process harmonization, etc. * 30% Site leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. * 30% Department leadership: * Overall responsibility for the site Quality Assurance and regulatory compliance functions including (but not limited to) those responsibilities listed below. * Oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development counselling, informal and formal performance appraisals and feedback, and talent development/succession planning. * 10% Personal Leadership: Professional development, managing work-life balance, strategic planning, etc. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Internal Investigations on cGMP issues, trends, and customer complaints * Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity * Oversite of data Integrity programs, process integration and procedural harmonization with other CSS sites, raw materials and finished goods release processes, and Environmental Monitoring Program * Customer and Regulatory Audits, including coordination and submission of Catalent responses * Communication and escalation of quality issues to Site Leadership Team and QA senior management * Site Training program * Supplier and internal audits (including coordination with IACP program) * Site Label Control, including review, release and approval process * In-process QA activities, including line clearance and room release, in-process and receiving inspections, and raw material/product sampling * Implement Global quality policies and standards and CSS network procedures at the site * Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate * Other duties as assigned. The Candidate: * Bachelor's Degree in Science, Engineering, or Pharmaceutical discipline or related scientific field required; * A minimum of ten (10) years' experience working in a chemical, pharmaceutical, food or relevant industry with at least five (5) years' of experience in Quality Assurance or Regulatory Affairs with progressive responsibilities; * Experience in managing people, providing leadership, and implementing developmental plans for personnel required; * Direct experience and working knowledge of Validation principles, including validation of processes, equipment, systems, analytical methods, cleaning, and transportation; * Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies; * Must have a demonstrable record of implementing and maintaining quality systems; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics * Must be resourceful, possess strong time management skills and be able to work with minimal or no supervision to achieve deadlines and objectives. * Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience; Pay The anticipated starting salary range for this role in San Diego, CA is $180,000 to $205,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer and this salary range may not reflect positions that work in other states. Why You Should Join Catalent: * Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance). * Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions. * Paid Time Off Programs including Vacation, banked time, and personal time. * Employee Reward and Recognition Programs. * Opportunities for professional and personal development. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

The Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and resources. They do this to support customer operational and financial needs such as reimbursement information and contract adherence in an effort to help the provider or system increase their immunization rates among appropriate patients and help protect them from vaccine preventable diseases. The Vaccine Customer Representative (VCR) is the primary point of contact for a variety of customers within their assigned geography. These customers may include health care providers such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. Within their geography there are a diverse set of health care locations that they will call upon in order to execute their role including: clinics, health departments, integrated delivery systems, and hospitals. The VCR is a key member of the local Customer Team that works collaboratively with other field-based employees such as the Vaccine Key Customer Leader (VKCL), Vaccine Medical Affairs Leader (VMAL), Region Medical Director (RMD) as well as other members of the extended team. Territory Information: This territory covers San Diego, CA including but not limited to National City, El Cajon, and El Centro. The ideal location to reside is within this territory. Travel (%) varies based on candidate's location within the geography. The primary activities include: Engaging in balanced product sales presentations with Health Care Providers and Health Care Business Professionals to align customer needs and our Company's vaccine attribute in accordance with product labeling, and CDC and professional society recommendations. Providing Company Vaccine management with updates on customer needs as it relates to helping them improve patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals. Providing customers with key insights by keeping apprised of professional and health care environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of our Company's promotional materials. Utilizing analytical skills and tools to engage customers in quarterly business reviews regarding their vaccine contract to educate customers on the best ways to maximize their contract performance across the Company portfolio. Assisting customers with education to improve their organization's immunization rates through adherence to quality-based programs using appropriate tools such as Vaccine IQ. Regularly monitoring their business performance against objectives using company provided tools. Developing a territory level business plan that focuses on improving immunization rates with assigned customers in accordance with Our Company's policies, standards, and ethics. Maintaining product knowledge and certification on the entire Company vaccine portfolio along with knowledge of the CDC immunization schedule for both pediatric and adult vaccines. Specifically: Within select customer accounts, acts as primary point of contact for the customer, meet with key customers/personnel to maintain understanding of their current practice structure, business model, and key influencers (Managed Care Organization/payers, employers, state policy), and their patients' needs. Identifies business opportunities and makes information available to relevant stakeholders to support the identified immunization needs. For select customer accounts, coordinate with our Company's customer team (Account Executives, Integrated Delivery System team, Solutions support teams, etc.) to outline customer strategy for interactions/relationships aimed at improving immunization rates. Position Qualifications: Education: Bachelor's Degree with 0-3 years Sales experience OR a minimum of high school diploma with at least 4 years of relevant work experience which could include: professional sales, experience in marketing, military, or healthcare/scientific field (pharmaceutical, biotech, or medical devices). Required Skills: Demonstrated aptitude to excel in current or previous educational or professional roles Ability to work both independently and within a team environment Strong organizational and time management skills Excellent interpersonal and communication skills Other Requirements: Valid Driver's license Preferred Skills/Experience: Ability to convey technical concepts accurately and clearly Prior experience working in a technical/scientific field or healthcare environment Previous sales, account management, consultative, or customer service experience Experience developing and executing a plan for engaging customers and meeting customer needs Understanding of Marketing/Sales &/or Marketing/Sales Support Functions/Operations Ability to analyze metrics to assess progress against objectives Vaccine's experience Required Skills: Account Management, Account Management, Business Management, Business Opportunities, Business Performance Management, Business Reviews, Customer Accounts, Customer Experience Design, Customer Experience Management, Customer Needs Assessments, Customer Relationship Management (CRM), Customer Service Management, Customer Strategy, Health Economics, Immunizations, Interpersonal Relationships, Lead Generation, Managed Care, Market Analysis, Medical Affairs, Product Knowledge, Sales Forecasting, Sales Metrics, Sales Operations, Sales Pipeline Management {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $77,700.00 - $122,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 12/13/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

+ **Work Schedule:** Monday-Friday, core hours 6am-2:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds. The Washroom Operator I is responsible for executing equipment cleaning with a strong emphasis on equipment disassembly and accountability of equipment parts within the washroom. This individual will function as a member of the Equipment Team, and you will work with multiple departments across the local organization. This role offers immediate training on Good Manufacturing Practices (GMP). **The Role:** + Support disassembly of manufacturing equipment prior to cleaning. Participate in manufacturing equipment cleaning + Prepare solutions for manufacturing equipment cleaning + Maintain accountability of equipment parts throughout the cleaning process and maintain organization and cleanliness of the washroom + Support re-stocking of washroom supplies and cleaning of the Equipment Storage Areas + Maintain accuracy within the SIMON database with equipment activity updates + Maintain a high-quality standard of work and encourage strong teamwork and morale + Other duties as assigned **The Candidate:** + High School Diploma/GED required + No experience in a GMP environment is required, but it's highly preferred to have at least one (1) year of experience. Must be able to follow instructions (oral/written) + Knowledgeable with use of hand tools and Microsoft Word, Excel, and Outlook + Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of PPE/respirator frequently **Pay:** + The anticipated salary range for this role in California is $40,000 to $46,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

+ **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Packaging Technician for our Clinical Supply Services group will work in a team environment to offer quality packaging and labeling of customers' clinical trials. This Packaging Technician will be involved with handling look-alike products and labeling. Clinical operations projects may be a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. The Packaging Technician will also be involved with de-inking of products and capsule manufacturing. This individual must be detail oriented in order to work with multiple look-alike products at the same time. **The Role:** + Fill tablet, bottle, desiccant and closure hoppers. Hand count product using counting trays. Manufacturing responsibilities include de-inking product, tablet breaking, product placement into oversized capsules and capsule inspection. Work independently on assigned look-alike product and multi-fill projects + Inspect bottles for misalign closures, print registration and missing print copy, inspect seal integrity of pouch, print registration and missing print copy, inspect blister units and place them into properly assigned card locations for multi-fill operations; inspect blister cavities for missing product, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity + Responsible for cleaning machine equipment and production rooms as stated in cleaning SOP's (Standard Operating Procedure). Fill in all appropriate information in the cleaning logbooks as well as responsible for cleaning production rooms with three bucket sponge mop cleaning system which includes ceilings, walls and floors + All clinical labels must be inspected and require a 100% accountability. Clinical labels can be either manually or automatically applied + Sealed clinical cards must be inspected for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product + Inspection required for vials, ampoules and syringes utilizing black and white light boxes + Cold storage packaging will also be required working with cold product both outside and inside refrigeration conditions. Assembly work required which may include utilizing barcode scanning equipment and computers + Other duties as assigned **The Candidate:** + High School Diploma/GED or equivalent required + Two (2) years of previous production or warehouse experience preferred + Ability to read and understand customer specifications, cGMP's and Standard Operating Procedures (SOPs) + Must be able to follow written and oral instructions in an accurate manner, and effectively communicate, must be attentive, have a neat appearance and good personal hygiene, possess the ability to work in a fast-paced environment, work well in a team environment and troubleshoot problems and report issues + Must be able to work overtime as required + Physical requirements: able to perform duties which include cleaning and sanitation of rooms, including but not limited to mopping of walls, floors and ceilings, sanitation of machinery and equipment; Must be able to lift up to 40lbs and work in temperature-controlled freezers/fridges **Pay:** + The anticipated salary range for this role in San Diego, CA is $46,000 to $48,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego, CA is hiring a Senior Scientist in Analytical Development. An individual at the level of Senior Scientist, Analytical Development will be expected to either lead projects independently or build a team focused on the development of analytical methods for small molecule, peptide drug products and amorphous intermediates. This individual may be required to have direct reports depending on growth and ability. The focus of this role will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, and chiral. In addition, the individual may be responsible for overseeing development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products. The Senior Scientist, Analytical Development will be required to assist QC/QA in investigations as an SME. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP (Good Manufacturing Practices) regulations, as appropriate. This is a full-time salaried position Monday-Friday on 1st shift (day shift) with flexibility. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Develop stability-indicating methods for peptide and small molecule API (Active Pharmaceutical Ingredient), amorphous intermediates, and drug products from scratch. Develop cleaning verification methods. * Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing. * Troubleshoot and optimize analytical methods for characterization of drug products and intermediates. Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues' work for scientific accuracy and compliance. Responsible for transfer of analytical methods to other sites as required. Collaboration with other departments to troubleshoot technical issues. * Communicate results both internally and externally through oral and written updates and formal reports as necessary. Organize meetings and monitor all client interactions independently. Supervisor will be notified if their assistance is needed. * Assist in the creation and/or revision of new department-wide and site-wide procedures and company SOPs. Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues. * Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent's services. Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate. Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision. * Hire, train, and supervise analytical group members as necessary. Develop junior personnel for advancement within the team. Suggest and lead continuous improvement projects. * Other duties as assigned. The Candidate: * A Bachelor's (BS) degree is required in a physical, chemical, biological, or pharmaceutical science with a minimum of six years of experience in analytical development for small molecules/peptides. We will also accept a Master's (MS) with five years' experience, or a PhD with three years of experience. * Applicable experience entails: analytical development and method development with instrumentation including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC - reverse-phase, ion, and chiral), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing. * Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. * Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 25 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently. Pay: * The anticipated starting salary range for this role in San Diego, CA is $120,000 to $130,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Quality Assurance (QA) Associate I, Manufacturing Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This individual will be responsible for evaluating the compliance of documents such as batch records, equipment records, environmental monitoring records, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills. This is a full-time hourly position on 1st shift Monday-Friday. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: * Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP (Good Manufacturing Practices) regulations * Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents * Liaison between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status * Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections * Reviews and approves GMP product labels * Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs * Other duties as assigned The Candidate: * High school diploma/GED is required, Bachelor's degree desirable * Experience is preferred in GXP manufacturing environment or similar * Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude * Physical requirements: must be able to lift up to 50lbs and walk, stand, or sit for extended periods of time Pay: * The annual pay range for this position in California is $55,000 - $65,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

+ **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Process Excellence & Change Management Champion will play a pivotal role in driving process improvements and managing change within the site and the Clinical and Specialty Services segment. This position is responsible for supporting the implementation of new systems, Standard Operating Procedures (SOPs), and Work Instructions (WIs), ensuring GMP compliance, and fostering a culture of continuous improvement. The individual will work closely with the Process Excellence central team to drive system and process adoption using key change management strategies. **The Role:** + Lead change management initiatives for new systems, SOPs, and Work Instructions. Collaborate cross-functionally and with the Process Excellence central team to drive system and process adoption + Develop, author and update SOPs and work instructions to align with best practices. Supports training and optimization of those procedures + Assist in User Acceptance Testing (UAT) to ensure successful system implementation + Promote and lead operational excellence and continuous improvement initiatives within the site to enhance operational efficiency. Ensure all processes comply with GMP standards + Continuously seek opportunities for process optimization, cost reduction, and innovation through the application of new technologies, best practices, and lessons learned from operational experience + Facilitate cross-functional problem-solving events. Participate in and facilitate Rapid Response Team fact gathering + Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events + Other duties as assigned **The Candidate:** + Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is required. Lean Six Sigma Green Belt certification is highly desirable + Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs + Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment + Thorough knowledge of systems - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc. + Work independently or as part of a team, adopting a right-first-time approach ensuring the commitments are met in a timely manner. Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients. + Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to communicate effectively with internal and external customers, peers and managers + Physical requirements: able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally **Pay:** + The anticipated salary range for this role in San Diego, CA is $80,000 to $90,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

+ **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the Specialist drives root cause analysis (RCA), leads cross-functional problem-solving sessions, and develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards. **The Role:** + Participate in and facilitate Rapid Response Team fact gathering + Write Investigation reports - These written reports will clearly communicate what happened, why it happened, when it happened + Propose CAPAs - how to prevent event from happening in the future. Author SOPs and work instructions + Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events + Review investigation documentation for Out of Spec/Trend (OOS/T) or atypical results, as well as deviations from regulations, corporate policy or site procedures + Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner + Facilitate cross-functional problem-solving events. Communicates clearly with internal and external clients, both verbal and written. Use clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks + Other duties as assigned **The Candidate:** + High School Diploma/GED required. Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is highly preferred. Lean Six Sigma certification is highly desirable + Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs + Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment + Preferred knowledge of systems - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc. + Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time. Must be able to communicate effectively with internal and external customers, peers and managers + Physical requirements: able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally **Pay:** + The anticipated salary range for this role in San Diego, CA is $80,000 to $90,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

**Project Manager (Clinical Supply)** + **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Project Manager (PM) for our Clinical Supply Services group will independently lead project teams in the management and successful delivery of assigned projects and client relationships. The Project Manager will be responsible for communicating with internal and external clients and working as an advocate for Catalent and clients alike. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. **The Role:** + Coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion. Accurately forecast M&P revenue, PM revenue, and supply chain to support S&OP and site forecast process + Lead the implementation of new clinical and/or commercial projects including aspects of material qualification, master batch records, process validation, validation master plan and commercial supply agreements. Utilize and drive Smartsheet/Workfront timeline for day-to-day project activities and become proficient with JD Edwards ERP + Attend and produce minutes and actions for client meetings/teleconferences/client visits and audits to support assigned projects or PM team and understand full scope requirements to generate all required project documentation + When leading commercial projects, determine approach to be utilized, plan and help execute work independently with minimal supervision. Take a lead role in successful and timely launch and subsequent campaigns + Receive, monitor and manage client supplied label text/randomizations, drug, components and materials and ensure delivery to internal functions as required. Generate required documentation and liaise with depot group for 3rd party depot set up + Manage inventory reporting and monitor and track client inventory in line with project requirements. Set up clients on Fusion suite as required. Provide ongoing support for client use and password management. Set up returns phase of projects, generate, manage and monitor inventory reports and destruction process ensuring invoicing is completed + Collect KPI data and provide to internal teams and client. Assist with departmental training and completion of training documentation. Will mentor junior project managers and project coordinators + Will review contracts, investigate and propose solutions for disputed invoices, and effectively manage invoice queries to ensure timely resolution and payment. Assist in the preparation and regular review of Standing Operating Procedures relating to own areas of responsibility + Other duties as assigned **The Candidate:** + Bachelor's Degree and Project Management Professional (PMP) highly preferred. High School Diploma/GED required as a minimum + One (1) year of customer service or client-facing PM role preferred, but ideally four (4) years or more within the pharmaceutical or clinical supply chain field + Preferred experience in leading the initiation of projects in a cGMP regulated industry or validation experience with commercial pharmaceutical projects, knowledge of commercial supply agreements, validation master plans, process validation and rolling forecasts + Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently **Pay:** + The anticipated salary range for this role in California is $95,000 to $105,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

+ **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds. This is a very cross-functional position which is responsible for supporting various groups and sites in Business Development, Product Development, Manufacturing, and external clients. This individual is accountable for scoping, writing, pricing, issuing and management of proposals for new and existing customer opportunities, pipelines, and technical services. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. **The Role:** + Prepare development, tech transfer, clinical supply, and pipeline proposals related to customer activities within Catalent facilities. Examples would be an early phase product development proposal or a proposal to change a process. Key interactions in this process will include Business Development, Science and Technology (S&T), Product Development (PD), Analytical Services, and the site management as applicable + Responsible for designing and managing proposals for the site. Interact with various internal groups such as legal, business development, S&T, PD, Analytical, Quality, and project management for necessary information for the completion of quotes and Quote Amendment Records (QARs) + Collaborating as necessary with other Catalent sites to ensure the established project timelines and deliverables are progressing according to the agreement. Generate high level timeline and provide other documents when needed to support requested quotations + Ensuring that project quotes are within scope and up to date. Manage timelines of proposal development, and assure that documents are complete, accurate, and sent on time. Responsible for making sure each quote is governed by the correct legal document + Maintain weekly Quotes in Process (QIP) status for assigned proposals and manage other metric tracking as needed. Engage directly with clients for relevant QIP's. Will lead complex quotations requiring discussions and input from multiple locations or business units and senior Catalent leadership + Participates in continuous improvement and cross-functional initiatives to reduce cost and improve efficiency and service levels for both internal and external clients. Provide support as needed to the site, BD, or Commercial Operations Leadership and manage Strategic Clients + Will serve as the lead for mentoring and training support to new team members + Other duties as assigned **The Candidate:** + Bachelor's degree is required in a scientific, engineering, business, or relevant discipline + Must have six (6) years of relevant experience in pharmaceutical, medical device or food manufacturing, with experience in quality, technical project management, business management and/or business development + Must have relevant industry knowledge of drug product development and/or consumer product development, analytical research and development, project scale-up, product manufacturing, quality, validations, and regulatory + Must have strong business acumen along with analytical and financial skills. Advanced skills in Microsoft Office (Word, Excel, etc.) are required + Self-motivated, collaborative, action oriented. Demonstrated ability to work cross-functionally in a matrix organization + Physical Requirements: Individual needs to be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently **Pay:** + The anticipated salary range for this role in California is $90,000 to $105,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Work Your Magic with us! Start your next chapter and join EMD Electronics. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: The Operations Technician will be part of the Chemical Manufacturing team in Carlsbad, CA. The team of Operations Technicians are responsible for receiving, decontaminating, rebuilding, and filling our vessels with ultra-pure chemistries. Specific Responsibilities Include: Conduct manual and automated decontamination of vessels Perform hazardous waste consolidation Perform weekly and monthly regulatory compliance activities Acid-wash stainless steel and quartz vessels Maintain a clean and organized manufacturing environment Support receiving by unloading trucks Assist the Engineering team with troubleshooting system issues Perform data entry task Document and Inspect vessels to ensure quality Physical Attributes: Wear a full-face air-purifying respirator and other PPE Lift up to 50 pounds Location/shift: Onsite position in Carlsbad, CA - day shift Who You Are Minimum Qualifications: High School Diploma or GED 1+ years working in chemical, manufacturing or production. Preferred Qualifications: Experience handling chemicals Background in a fast-paced manufacturing environment Strong skills in troubleshooting, documentation, and communication Ability to read and understand Safety Data Sheets and written work instructions High focus on quality and safety Proficient using Microsoft suite (Word, Excel, Access, SharePoint) Experience with SAP Ability to use hand tools Pay Range for this position: $23.00 - $36.00/hour The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

* Work Schedule: Monday-Friday, core hours 8am-4:30pm * 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds. The Scientist 3 in our Analytical Development group will independently lead projects under minimal supervision and potentially supervise 1-2 team members. This individual will primarily support development of analytical methods for small molecules, peptides, and amorphous intermediates with a focus in H/UPLC-UV stability indicating methods (reverse phase, ion-exchange, chiral). You will also support the development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products and amorphous intermediates. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: * Develop cleaning verification methods and stability-indicating methods for peptide and small molecule Active Pharmaceutical Ingredients (API), intermediates, and drug products from scratch * Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, Gas Chromatography (GC), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing * Troubleshoot and optimize analytical methods for characterization of drug products and intermediates. Perform qualification studies to determine if methods are suitable for transfer to Quality Control * Communicate results both internally and externally through oral and written updates and formal reports as necessary. Independently lead discussions with clients on technical topics relating to their project * Exercise technical discretion and critical thinking in the design, execution and interpretation of experiments independently with minimal supervisor assistance. Data interpretation should be conducted independently * Assist in the creation and/or revision of new department-wide and site-wide procedures and company SOPs. Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues' work for scientific accuracy and compliance * Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues, and collaborate with other departments to troubleshoot technical issues. Familiarity with current GMP regulations is required * Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent's services. Individuals will proactively communicate strategy to clients and work with their supervisor or Business Development to generate new proposals or change orders. Individuals will support the business aspects of their position by working with their supervisor to perform billing communication for all work proposals under their supervision * Other duties as assigned The Candidate: * Bachelor's of Science degree is required plus a minimum of four (4) years of analytical development experience * We will also accept a Master's of Science plus a minimum of three (3) years of analytical development experience OR a PhD with at least one (1) year of analytical development experience * Familiarity with current GMP regulations * The preferred candidate will have proficiency in the qualification of analytical test methods for API, intermediates, and final drug products, particularly HPLC and UPLC stability-indicating assays, GC, dissolution methods, and water content methods. The individual should also have experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM. The individual will be responsible for developing product-specific cleaning methods to support use of GMP manufacturing equipment * Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently Pay: * The anticipated salary range for this role in California is $117,000 to $130,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

**Associate Project Lead, Pre-production** **(Clinical Supply)** + **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Associate Project Lead (PL) will support pre-production teams in the management and successful delivery of assigned Projects for our Clinical Supply site. The Associate Project Lead serves as a liaison between cross functional teams to ensure project success while complying with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). Primary responsibilities of this position include activities related to supply chain, procurement, batch record and label creation, and other project management and coordination activities affiliated with assigned projects. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. **The Role:** + Development of clinical, stability, and commercial packaging protocols and materials. Develop strategic production plans and timelines. Lead discussions on strategic matters + Attend client meetings and produce minutes and actions for internal client meetings/teleconferences/client visits and audits to support PL team and understand full scope requirements to generate all required project documentation. Ensure key project milestones are delivered timely with quality and integrity. Generate required documentation and liaise with clients as needed + Will become proficient in Enterprise Resource Planning (ERP) system JD Edwards, and perform all project set up entries and tracking as needed for all assigned projects and responsible for marking financial milestones + Coordinate production preparation activities. Create batch records based on project source documentation including primary, secondary labeling and kitting and assembly. Interact with cross functional teams to communicate project requirements and gather appropriate paperwork for batch records. Provide batch record training to production team on complex processes + Item Master identification and creator of request forms, JD Edwards Router, Bill of Materials (BOM), Purchase Order, and Work Order creation, Clinicopia, and GSA set up. Create Change Orders and drive resolution to changes required during production. Obtain item numbers for labels and randomization copies for batch records. Support Label proof design and label printing + Coordinate packaging, receiving and distribution activities, related to item master requests, zero-dollar purchase order generation, shipment request completion. Support procurement activities of needed project materials in timely, efficient and cost-effective manner. Support material onboarding for vendor-procured and client-supplied materials + Understand and adhere to standard operating procedures (SOPs) in a GMP setting. Support service complaint investigations + Other duties as assigned **The Candidate:** + High School Diploma/GED is required with a minimum of one (1) year of relevant experience in clinical supply, project management, or pharmaceutics. We will also accept a Bachelor's degree with no experience, but candidates with one year of GMP technical writing and/or packaging experience are highly preferred + Experience with preparation of batch records, packaging, labeling, assembly, supply chain, procurement and distribution of clinical trial materials, pharmaceutical/biotech environment is preferred + Thorough knowledge of systems is preferred - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS (Electronic Document Management System), etc. + Excellent written and verbal communication skills for client communication and exceptional internal and external customer service skills is required. Proactive, with superior time management, organizational skills, and detailed oriented. Able to prioritize, manage multiple tasks and stressful situations. Able to work independently, as a team, motivate cross functional teams to meet deliverables on time. Problem solving and solutions oriented. Focus on quality and integrity with right first-time approach and a positive attitude + Physical Requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds; Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential to receive ordinary information and to prepare or inspect documents. Must be able to visually differentiate colors. Good manual dexterity for the use of common office equipment **Pay:** + The anticipated salary range for this role in California is $70,000 to $75,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

Project Manager (Clinical Supply) * Work Schedule: Monday-Friday, core hours 8am-4:30pm * 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Project Manager (PM) for our Clinical Supply Services group will independently lead project teams in the management and successful delivery of assigned projects and client relationships. The Project Manager will be responsible for communicating with internal and external clients and working as an advocate for Catalent and clients alike. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: * Coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion. Accurately forecast M&P revenue, PM revenue, and supply chain to support S&OP and site forecast process * Lead the implementation of new clinical and/or commercial projects including aspects of material qualification, master batch records, process validation, validation master plan and commercial supply agreements. Utilize and drive Smartsheet/Workfront timeline for day-to-day project activities and become proficient with JD Edwards ERP * Attend and produce minutes and actions for client meetings/teleconferences/client visits and audits to support assigned projects or PM team and understand full scope requirements to generate all required project documentation * When leading commercial projects, determine approach to be utilized, plan and help execute work independently with minimal supervision. Take a lead role in successful and timely launch and subsequent campaigns * Receive, monitor and manage client supplied label text/randomizations, drug, components and materials and ensure delivery to internal functions as required. Generate required documentation and liaise with depot group for 3rd party depot set up * Manage inventory reporting and monitor and track client inventory in line with project requirements. Set up clients on Fusion suite as required. Provide ongoing support for client use and password management. Set up returns phase of projects, generate, manage and monitor inventory reports and destruction process ensuring invoicing is completed * Collect KPI data and provide to internal teams and client. Assist with departmental training and completion of training documentation. Will mentor junior project managers and project coordinators * Will review contracts, investigate and propose solutions for disputed invoices, and effectively manage invoice queries to ensure timely resolution and payment. Assist in the preparation and regular review of Standing Operating Procedures relating to own areas of responsibility * Other duties as assigned The Candidate: * Bachelor's Degree and Project Management Professional (PMP) highly preferred. High School Diploma/GED required as a minimum * One (1) year of customer service or client-facing PM role preferred, but ideally four (4) years or more within the pharmaceutical or clinical supply chain field * Preferred experience in leading the initiation of projects in a cGMP regulated industry or validation experience with commercial pharmaceutical projects, knowledge of commercial supply agreements, validation master plans, process validation and rolling forecasts * Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently Pay: * The anticipated salary range for this role in California is $95,000 to $105,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego, CA is hiring a Senior Scientist in Analytical Development. An individual at the level of Senior Scientist, Analytical Development will be expected to either lead projects independently or build a team focused on the development of analytical methods for small molecule, peptide drug products and amorphous intermediates. This individual may be required to have direct reports depending on growth and ability. The focus of this role will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, and chiral. In addition, the individual may be responsible for overseeing development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products. The Senior Scientist, Analytical Development will be required to assist QC/QA in investigations as an SME. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP (Good Manufacturing Practices) regulations, as appropriate. **This is a full-time salaried position Monday-Friday on 1st shift (day shift) with flexibility.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Develop stability-indicating methods for peptide and small molecule API (Active Pharmaceutical Ingredient), amorphous intermediates, and drug products from scratch. Develop cleaning verification methods. + Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing. + Troubleshoot and optimize analytical methods for characterization of drug products and intermediates. Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues' work for scientific accuracy and compliance. Responsible for transfer of analytical methods to other sites as required. Collaboration with other departments to troubleshoot technical issues. + Communicate results both internally and externally through oral and written updates and formal reports as necessary. Organize meetings and monitor all client interactions independently. Supervisor will be notified if their assistance is needed. + Assist in the creation and/or revision of new department-wide and site-wide procedures and company SOPs. Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues. + Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent's services. Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate. Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision. + Hire, train, and supervise analytical group members as necessary. Develop junior personnel for advancement within the team.Suggest and lead continuous improvement projects. + Other duties as assigned. **The Candidate:** + A Bachelor's (BS) degree is required in a physical, chemical, biological, or pharmaceutical science with a minimum of six years of experience in analytical development for small molecules/peptides. We will also accept a Master's (MS) with five years' experience, or a PhD with three years of experience. + Applicable experience entails: analytical development and method development with instrumentation including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC - reverse-phase, ion, and chiral), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing. + Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. + **Physical Requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 25 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently. **Pay:** + The anticipated starting salary range for this role in San Diego, CA is $120,000 to $130,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

**Quality Assurance (QA) Associate I, Manufacturing** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. Catalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This individual will be responsible for evaluating the compliance of documents such as batch records, equipment records, environmental monitoring records, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills. **This is a full-time hourly position on 1st shift Monday-Friday.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP (Good Manufacturing Practices) regulations + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents + Liaison between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status + Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections + Reviews and approves GMP product labels + Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs + Other duties as assigned **The Candidate:** + High school diploma/GED is required, Bachelor's degree desirable + Experience is preferred in GXP manufacturing environment or similar + Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude + **Physical requirements:** must be able to lift up to 50lbs and walk, stand, or sit for extended periods of time **Pay:** + The annual pay range for this position in California is $55,000 - $65,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .

* Work Schedule: Monday-Friday, core hours 8am-4:30pm * 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds. The Scientist 1 in our Analytical Development group will independently plan and execute simple laboratory experiments and clearly communicate the status of projects to cross-functional team members, management, and clients. This individual will support the qualification of analytical test methods for Active Pharmaceutical Ingredients (API), intermediates, and final drug products using a variety of chromatography techniques (H/UPLC, GC), physical characterization techniques (TGA, DSC, PXRD, GVS, SEM) and dissolution/water content methods. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: * Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, Gas Chromatography (GC), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing * Develop cleaning verification methods and execution of excipient compatibility and forced degradation studies, under supervision * Troubleshoot and optimize analytical methods for characterization of drug products and intermediates * Perform qualification studies to determine if methods are suitable for transfer to Quality Control. Simple experimental design and execution will be performed independently. Complex design may need supervisor assistance * Data interpretation should be conducted with limited guidance. Individuals will be able to identify key factors from data and understand the importance of the findings. Clear and accurate record keeping in laboratory notebooks and some secondary review of other colleagues' work for scientific accuracy and compliance * Increase in client interaction will be a focus. Individuals may lead discussions with clients on technical topics relating to their project * Individuals should have a good general foundation of scientific principles, chemistry concepts, and be proficient in core analytical scientific techniques, GMPs, and technical writing * Other duties as assigned The Candidate: * Bachelor's of Science degree is required plus a minimum of one (1) year of analytical development experience * We will also accept a Master's of Science without any formal industry experience, but highly preferred to have two (2) years of experience in analytical development * The individual must have demonstrated proficiency in the qualification of analytical test methods for API, intermediates, and final drug products, particularly HPLC and UPLC stability-indicating assays, GC, dissolution methods, and water content methods. The individual should also have experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM. The individual will be responsible for developing product-specific cleaning methods to support use of GMP manufacturing equipment * Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently Pay: * The anticipated salary range for this role in California is $78,000 to $85,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. * Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. * Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. * Several Employee Resource Groups focusing on Diversity and Inclusion. * Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. * 152 hours of PTO + 10 paid holidays. * Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. * Tuition Reimbursement - Let us help you finish your degree or earn a new one! * WellHub program to promote overall physical wellness. * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

+ **Work Schedule:** Monday-Friday, core hours 8am-4:30pm + 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds. This is a very cross-functional position which will lead projects as an individual or build a team focused on oral formulation development for small molecules or peptide drug products and amorphous intermediates. The primary formulation platforms will include tablets, capsules, granules, beads, solutions, suspensions, immediate or extended-release dosage forms, and amorphous intermediates. The individual will research and introduce new formulation technology to produce and characterize drug products and will be the primary point of customer contact for formulation strategy, compliance, and troubleshooting. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. **The Role:** + Creates and develops innovative drug formulations using the techniques described above. Has a thorough understanding Good Manufacturing Practice (GMP) and Investigational New Drug (IND-enabling) formulation strategies. Selects and evaluates container/closure systems and storage conditions with limited supervision + Performs and trains others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, suspensions, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling, spray drying. Performs and trains others on a variety of characterization techniques (such as pH, osmolality, viscosity, particle size, DSC, PXRD, SEM, TGA, DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography) + Independently responsible for the successful transfer of formulation projects to the GMP manufacturing team and for collaboration with process engineering team during technology transfer. Responsible for transfer of projects to external manufacturers, or late stage/commercial manufacturing sites within Catalent + Communicates results both internally and externally through oral and written updates and formal reports as necessary. Organize meetings and monitor all client interactions independently. Participate in and lead cross-functional teams + Performs secondary review of other colleagues' work for scientific accuracy and compliance. Creates and/or revises new department-wide and site-site procedures and company Standard Operating Procedures (SOPs) + Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate. Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision + Hire, train, and supervise formulation group members as necessary. Develop junior personnel for advancement within the team. Participate in Business Development and Marketing activities by generating scientific expert content, hosting new client visits or teleconferences, and attending conferences or client visits to generate new leads + Responsible for maintaining a GMP laboratory environment and maintaining a safe, clean laboratory. Suggest and lead continuous improvement projects + Other duties as assigned **The Candidate:** + 4-year degree (Bachelor's/B.S.) in a physical, chemical, biological, or pharmaceutical science required plus a minimum of six (6) years of drug product development experience. We will also consider candidates who have a Master of Science (M.S.) with five (5) years' experience, or PhD with three (3) years of experience in drug product development + Preferred to have management experience; this person will immediately manage two people with the potential to manage a team of up to 6 in the future + Preferred to have oral formulation development experience (Tablets, capsules, granulation, spray dried dispersion/amorphous dispersions) + Strong preference for early phase development (preclinical, phase I-II with new APIs/small molecules), but will consider candidates with late stage or generics experience if they are a strong manager & communicator + Experience in a client-facing role is a plus due to regular communication with internal/external stakeholders + Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience + **Physical Requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 25 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently **Pay:** + The anticipated salary range for this role in California is $132,000 to $140,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. + Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. + Several Employee Resource Groups focusing on Diversity and Inclusion. + Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. + 152 hours of PTO + 10 paid holidays. + Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. + Tuition Reimbursement - Let us help you finish your degree or earn a new one! + WellHub program to promote overall physical wellness. + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .