Catalent Pharma Solutions jobs in Philadelphia, PA

* Work Schedule: Monday - Friday, 8:00am - 4:30pm * 100% on-site Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. This position is responsible for being the quality liaison between Philadelphia Quality Assurance and the client. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a Quality relationship. The Quality Program Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels within the organization. The Role: * Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests * Plan, schedule, manage, and host customer, corporate, and internal audits. Support regulatory inspections as required * Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions * Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective * Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered * Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff; Act as the primary contact with clients if there are quality questions on documentation, process questions, issues, etc * Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff * Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested * Other duties as assigned The Candidate: * Bachelor's degree is required, life sciences or scientific degree is preferred * Five years of relevant experience working in a pharmaceutical industry or life science industry is required * Must possess regulatory and/or client audit experience * Must have the ability to present Quality/ Compliance information both internally at Catalent and externally to clients * Knowledge of cGMP's is required Why you should join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives * 152 hours of PTO + 8 paid holidays * Generous 401K match * Medical, dental and vision benefits * Tuition Reimbursement - Let us help you finish your degree or start a new degree! 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.

Job Title: Fill Operator I - 2nd Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Fill Operator I. In this role, you will be responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitization, equipment cleaning, PM activities, airlock and ancillary room cleaning, etc. Key Responsibilities: * Maintains curriculum gowning qualifications. * Ability to perform all job duties using acceptable aseptic technique. * Sets up & operates automated filling and support equipment such as fillers, stoppering units and cappers. * Completes applicable paperwork and log book entries for the filling rooms in accordance with approved procedures. * Follows all written procedures for operation of the fill room. * Performs clean-up of equipment and room, including walls and floor, as necessary. * Collects samples, performs fill weight checks and other quality checks as necessary. * Assists with or performs preventive maintenance tasks on filling equipment, such as inspection and cleaning of machine parts, as may be required. * Refers process issues to Supervisor or designee. * Informs supervisor of maintenance and/or safety issues. * Works overtime with short notice when production requires. * Performs all other duties as determined by supervisor and management. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Minimum: 1 year experience operating production equipment and /or operating analytical instrumentation or 2 (two) years as a Clean Room Operator required. Language Skills: * Good oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs. Mathematical Skills: * Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Reasoning Ability: * Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to examine problem areas and make recommendations for corrective action. Must be able to comprehend and follow all applicable SOPs. Physical Demands: * Must be able to lift 15 lbs. Must be able to stand for long periods of time. * The cleaning function of the position requires frequent bending, twisting, pushing, pulling and lifting. * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: * Filling Operator I must work in filling suites totally gowned with mask, hood, coverall and gloves. At times environment can be confining. The noise level is moderate to loud. Use of hearing protection may be required. The use of sanitizing agents to clean the filling room may be moderately disagreeable. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Preferred Qualifications: * Prior aseptic technique training preferred but not required. Compensation: Hourly Rate: $23.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia

Job Title: Associate, DEA Compliance Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Associate, DEA Compliance. In this role, you will be responsible for guiding and supporting all DEA regulated business activities involved in the pharmaceutical manufacturing, analysis, and distribution of controlled substances. These activities include procurement, recordkeeping, chain of custody, production, distribution, and destruction. This position should also have the ability represent the company by interfacing with government agencies. Key Responsibilities: Regular and predictable onsite attendance and punctuality. Act as DEA Coordinator by monitoring and coordinating all DEA related actives at the Hikma Dayton, NJ facility. Train with staff and onsite activities at the Hikma Cherry Hill, NJ facility as needed. Work with Hikma Security to implement and maintain security control measures relating to the safekeeping of controlled substances. Monitor controlled substance quotas. Monitor chain of custody transfers throughout manufacturing and laboratory support operations. Ensure clear and efficient methods for maintaining Production Batch Record accountability. Report CSOS and ARCOS through the DEA website. Conduct inventories for initial, year-end, change in Pharmacist In Charge. Monitor and report the destruction of controlled substances. Work with Hikma Quality, Environmental, Health & Safety, and Logistic Teams. Review and develop policies and procedures relating to controlled substance compliance. Maintain a state of inspection readiness throughout all Controlled Substance Compliance activities. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Minimum: Bachelors' degree or equivalent with a minimum of 3 years' work experience or an equivalent overall level of knowledge based upon previous work experience. Preferred Qualifications: Experience in injectable manufacturing. Compensation: Base Salary: $56,950 to $95,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies. We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day. Job Summary Provide Administrative support to all PAB departments performing daily tasks and duties as well as any other clerical task or duty required or requested by Office Manager or Site Leadership. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Microsoft proficiency in Word, Excel, Teams and Outlook platforms * Greet and escort visitors around PAB as needed in a professional and friendly manner * Answer routine/basic questions and accommodate co-workers each shift in regard to office operations and established policies and procedures. * Administrative functions and projects as assigned by Office Manager * With guidance, handle special projects and duties as needed (for example, data collection, report creation, database maintenance, contacting personnel for routine updates, etc.). * Experience (non-proficiency) in PowerPoint, One Note * Prepare routine documents and forms as requested. * DocuSign proficiency following company-provided training * Stay current with and maintain training record and SOPs as required by company * Faxing, scanning and photocopying as needed * Maintain office supplies including inventory, rotation and ordering * Assist with stocking, inventory, maintaining, cleaning and organizing coffee pantries in both building locations (Malvern and Wayne) * Maintain and prepare office locations (workstations and offices) for existing and future employees. This may include cleaning, organizing and sanitizing workstations between employees. * Maintain, organize and sanitize conference rooms daily in the morning, throughout the day between uses and at the end of the day * Place, set up and arrange for catering, as needed. * Make meeting and travel arrangements, as needed. * Assist with calendar management, as needed. * Maintain and process expense reports, as needed. * Relay information and requests to department members and follow-up as needed. * Collate and distribute information. * Coverage of other Administrative functions between two business locations (Malvern and Wayne) * Receive and distribute mail. * Take messages and handle routine matters as they arise. * Establish and maintain files. Job Qualifications * Education: High School or G.E.D. and specialized secretarial training beyond High School. Associate's degree (A.A. /A.S.) or equivalent from two year college preferred. * Experience: Zero to two years related experience. * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. * Certification!Licensure: None. * Other: Ability to prioritize and multi-task. Good keyboarding skills, proficient in utilizing personal computer, e-mail and standard office software packages (word processing, spreadsheet, presentation, database). PHYSICAL DEMANDS: * While performing the duties of this job, the employee is regularly required to talk, hear and is frequently required to work/type at a computer. * Specific vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus. * Ability to lift up to 10 lbs. WORK ENVIRONMENT: * General office working conditions. * The noise level in the work environment is usually quiet. About Charles River Cell Solutions Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. Together, with over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. At Cell Solutions, we are passionate about our role in improving the quality of people's lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone's life. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231112

Job Title: Manufacturing Specialist - 1st Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. KEY RESPONSIBILITES The Manufacturing Specialist will assist the shift lead in a hands-on approach to overseeing production activities including, filling, sterilization, component and equipment prep, and compounding. Completes quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing recommendations. Interprets manufacturing policies, procedures, and programs Qualified to work in and operate equipment in the assigned area of responsibility (i.e., ability to be gown qualified). Assists the shift lead (supervisor) and Group Leader in ensuring production lines run efficiently and in a high state of compliance. Completes deviations, commitments, DCEs, and SOP revisions as necessary. Emphasize training and ensures training compliance. Support and emphasize the Safety and Quality commitments of the department. Analyze staffing needs. Responsible for driving operational excellence projects. Requires a B.S. in technical discipline with 0 to 3 years experience in manufacturing processes or 5 years experience in pharmaceutical injectables manufacturing as an alternative to a 4 year degree. Sound knowledge and understanding of cGMPs. Ability to manage multiple priorities and projects. Must work well as a member of a team. Good oral and written communication skills. Ability to communicate well-written and oral. Compensation: Salary Range: $56,950 to $95,000.00. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law

Job Title: Clean Room Operator - 3rd Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Clean Room Operator. In this role, you will be responsible for cleaning and disinfecting all aseptic and controlled production areas prior to each day's scheduled operation under cGMP's, SOP/Job Aids and Safety requirements. Key Responsibilities: Cleans/disinfects clean room walls, ceilings, windows, ledges, vents, light fixtures, hoods and floors throughout all aseptic cores and ancillary rooms on a daily basis. Disposes trash generated within work areas and places clean trash cans in their original locations. Must successfully complete gown qualification program and must maintain gown qualification. Uses all department equipment, including but not limited to vacuums, sprayers and foggers in a safe and efficient manner. Understands and complies with aseptic training guidelines. Reports all safety and maintenance concerns to immediate supervisor. Signs all necessary production records. Works overtime as required to support business needs. Performs other duties as determined by management personnel. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: High School diploma or equivalent. Prior production experience preferred. Language Skills: Ability to read and interpret written documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to complete required documentation such as production batch records. Ability to communicate orally and in writing. Mathematical Skills: Ability to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and/or decimals. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems in accordance with approved procedures. Physical Demands: On feet 80% of the time applying cleaning solutions and sanitizing agents on ceilings, walls and floors. Requires pushing or lifting 30-40 lbs over 50% of the time. Requires frequent bending, twisting, pushing, pulling and lifting. Work Environment: Must be gown qualified to work in a clean room environment. Production areas are usually wet. Hazards: Exposure to wet floors, strong chemicals and hot WFI. May incur minor cuts, abrasions, bruises, slight burns or muscle strains. Compensation: Hourly Rate: $20.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices. **Key Accountabilities** : **Oversight of programming activities:** + Clinical specimen management from collection through testing and final disposition + Ensures compliance with clinical protocol and informed consent. + Maintain chain of custody for specimens + Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens + Resolve and/or triage specimen queries from sites or vendors + Ensuring proper documentation of specimen destructions are obtained and filed appropriately **Collaborative relationships:** + Collaborate on implementation and maintenance of specimen tracking system + Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management **Compliance with Parexel standards:** + Complies with required training curriculum + Completes timesheets accurately as required + Submits expense reports as required + Updates CV as required + Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements **Skills:** + Effective project management and time management skills; able to prioritize successfully + Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession + Detail oriented; performs quality and accurate work with minimal oversight + Excellent written/verbal communication skills + Can identify opportunities for efficiency improvements and simplification, recognizes appropriate. + Resources for deliverables, has effective organizational skills + Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively + Flexible, easily adapts to change, and is energized by challenges and problem-solving + Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate + Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented + Proficiency in written and spoken English - required + Proficiency in local languages (as applicable) **Knowledge and Experience** : + Years of experience: 2-5 years; dependent on level of related skills and education + Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays + Proficiency with data sets and Excel, understanding of data relationships and metadata + Confident in overseeing vendors and communicating with experts to drive quality deliverables + Preferred: + Previous biobanking, sample tracking and handling experience + Previous LIMS (Laboratory Information Management System) experience + Working knowledge of the clinical drug development process + Working knowledge of the Food & Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT). + Oncology experience and/or working knowledge + Proficiency with timeline management **Education:** + Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Title: Principal Real World Research Delivery Lead (RWRDL)** Are you ready to take on a challenge and accelerate your career? This is an **excellent opportunity for a self-driven, autonomous leader** eager for growth and progression. Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative Real World Research (RWR) solutions for global clients. This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll **lead cross-functional teams** , manage **budgets and timelines** , and serve as the **primary client contact** for innovative RWD projects. We're looking for a **strategic project leader** with strong communication skills, adaptability, and a go-getter mindset. Experience in **RWD/RWE** , **data privacy** , and **drug development** is a plus. **Career Growth:** Shape new services, mentor emerging leaders, and gain visibility in a lean PM model. As a senior leader, you will: + **Lead cross-functional teams** and act as the primary client contact for complex RWR and RWD projects. + Oversee **project proposals, budgets, timelines, and milestones** while ensuring compliance with SOPs and data privacy standards. + Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions. + Mentor junior team members and help shape new services in a lean PM model. **What We're Looking For:** + Strong **project leadership experience** with proven ability to manage multiple projects and decentralized teams. + Excellent **communication skills** , adaptability, and a proactive, go-getter mindset. + Knowledge of **RWD/RWE methodologies** , data privacy, and drug development processes. + Ability to thrive in dynamic environments and lead independently. **Preferred Experience:** + RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research. + Understanding of RWD platforms, project management systems, and GCP environments. **Education:** Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred. **Why Join Us?** + **Career progression** and visibility in a growing RWD space. + Opportunity to **develop new services and mentor emerging leaders** . + Work on impactful projects that shape the future of clinical research. If you're ambitious, adaptable, and ready to make a difference, **apply today and lead the way in Real World Research!** \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Description** Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Other potential opportunities include method development/optimization, workflow optimization, and template development. **Responsibilities** + Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing + Results processing and documentation by following appropriate methods / protocols / procedures + Sample management and monitoring of controlled temperature units. + Following all appropriate laboratory safety and hygiene procedures **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab + MS (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab **Required Skills and Experience** + Must have separations experience for large molecules or plate-based assay experience. + Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques: + Liquid Chromatography (HPLC / UPLC) + Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) + Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF) + ELISA (HCP, proA) and binding potency assay + qPCR and basic molecular biology techniques (gel electrophoresis, etc.) + High-throughput liquid handling system, e.g., Tecan, Bravo, etc. + Basic instrumentation troubleshooting + **Ability and willingness to train in molecular biology and immunoassay testing** + **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)** **Desired Skills and Experience** + Familiarity with compendial testing such as UV 280, pH, and Physical Observations + **Ability to follow complicated scientific protocols / procedures** + Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases) + Good documentation practices & utilization in electronic lab notebooks (ELN) + Analytical software such as Empower. + Knowledge of Laboratory Information Management Systems (LIMS) + Sample submission & sample management + Monitoring of controlled temperature units + Experience with BSL2 (Biosafety Level 2) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Title: Regulatory Affairs Associate JOB PRUPOSE Responsible for ongoing support of regulatory activities, including preparation and submission of Annual Reports, Annual Product Reviews, foreign registrations, change controls and labeling review and proofreading. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to any deficiency letters. RESPONSIBILITIES * Reviews and approves labeling for revisions to current products. * Proofreads labeling drafts as requested by labeling. * Drafts revised labeling (Package Inserts) for marketed products based on FDA requirements and/or Hikma proposed changes. * Completes regulatory portion of Annual Product Reviews (APRs). * Reviews change control requests and provides regulatory opinion with supervisor concurrence. * Supports the collection of documents for foreign registration, including submitting requests to FDA for Certificate of Pharmaceutical Product. * Provides regulatory support to teams and gives updates at regulatory staff meetings, as needed. * Prepares and submits Annual Reports, supplements, amendments, and other correspondences to FDA. * Keeps Hikma's Ruby database current for all injectable products. QUALIFICATIONS * Exercise independent judgment. * Scientific knowledge. * Written and Verbal communication skills. * Strong Negotiation skills. * Extremely strong accuracy and attention to detail. * Ability to work independently, be flexible and accommodating as priorities may change. * Technical system skills (e.g. word processing, spreadsheets, databases, online research). * Manage multiple projects and deadlines. * Ability to identify compliance risks and escalate when necessary. EDUCATION AND/OR EXPERIENCE BS degree in a scientific discipline with 2 to 5 years' experience in the Pharmaceutical Industry along with excellent communication skills is required. Two (2) years of regulatory exposure is preferred. What We Offer * Clean climate-controlled working environment * Annual performance bonus potential * 401k employer match up to 6% of your contributions * 23 vacation/personal days * 11 paid Company holidays * Generous healthcare benefits * Employee discount program * Wellbeing rewards programs * Safety and Quality is a top organizational priority * Career advancement/growth opportunities * Tuition Reimbursement * Maternity and Parental Leave * Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia

Job Title: Process Operator I - PFS 2nd Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Process Operator I. In this role, you will be responsible for setting up, adjusting, maintaining and operating various pieces of equipment i.e. automatic glass washers, depyrogenation tunnels, cappers, tray loaders, and automatic bag openers. The Process Operator I is responsible for complying with all cGMPs, SOPs, equipment parameters and safety regulations. This job has no supervisory responsibilities. However, training of others is a requirement. Key Responsibilities: * Prepares equipment at start of lot. * Verifies incoming components for correctness using Order Number. * Set up and operates equipment throughout shift. * Monitors parameters i.e., machine speed, water pressure, temperature, belt speed, etc. periodically during the shift and records as required per SOPs and cGMPs. * Clean and clears equipment and work area at the beginning and end of each production run. * Maintains quality of machine output; including, but not limited to: * Reporting manufacturing/component deviations; including, but not limited to, visually defective glassware or components to the area Process Supervisor or designee. * Reporting process deviations to area Process Supervisor or designee. * Completes all required batch record and logbook paperwork. * Trains individuals on equipment, when required. * Maintains general housekeeping of equipment and area throughout shift. * Works overtime as required to support business needs. * Performs all other duties as assigned by management personnel. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Education: High School Diploma or Equivalent Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to complete required documentation. Mathematical Skills: Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and/or decimals. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Physical Demands: On feet 100% of the time while performing the duties of this job. Requires lifting 5-40 lbs continuously throughout the workday. Requires frequent bending, twisting, pushing, pulling and lifting. Work Environment: Noise level in the work environment is usually moderate to loud. Hearing protection may be required in some areas. The atmosphere in some work areas at times will be warm and humid. Compensation: Hourly Rate: $20.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia

Job Title: Mechanic I, Facility Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Mechanic I, Facility. In this role, you will be responsible for performing preventative maintenance, routine maintenance and submitted work orders to keep the facility buildings in good operation. Escorts and oversees contractors hired to complete facilities repairs: roofs, floors, doors, walls, office changes and renovations to ensure contractors are compliance with pharmaceutical rules. Maintains shop area of tools and equipment, orders items needed for repairs and stock. Assist other maintenance personnel when required. Performs other duties as assigned by the maintenance supervisor or engineers not necessarily related to the general duties. Key Responsibilities: * Regular and predictable onsite attendance and punctuality. * Spackle and caulk walls. * Meet and discuss repair issues will all personnel. * Escort of contractors and Pest control staff. * Office furniture relocation and repairs. * Investigating facility issues with use of ladders. * Assist with housekeeping equipment installations. * Masonry, patching walls and floors. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * High school diploma or equivalent. * Moderate physical exertion necessary as continual moving around the facility, lifting 30 to 40 lbs. may be required. * Ability to climb ladders to investigate above ceilings. * Routine and interpretive decision-making skills needed. Preferred Qualifications: * Trade school or carpentry skills a plus. Compensation: Hourly Rate: $25.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia

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. This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia is hiring a **Production Scheduler** . The packaging operations team at the Philadelphia facility is responsible for overseeing pharmaceutical clinical and commercial packaging operations, including drug product and DEA controlled substance. Primary and secondary packaging operations are executed at ambient through frozen temperature conditions in three buildings across campus. The **Production Scheduler** is responsible for developing and maintaining the detailed, short-term production schedules (daily to weekly) to optimize resource utilization within the actual, finite capacity of the plant. This includes daily collaboration between the Production Scheduler, Planning team and Packaging team and translating the plant schedule to ensure efficient, on-time production. **This is an onsite, full-time, hourly/salary role position: Monday-Friday: 8:00am-5:00pm -1st shift.** **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:** + Accountable for translating the master plant schedule to provide the detailed packaging schedule in a manner that is effectively executed by the Operations teams. + Responsible for clearly communicating schedule changes, potential disruptions, and performance data to all relevant departments and teams. + Partners across functional departments to effectively support batch readiness on the packaging floor + Monitors and reports key performance indicators + Analyzes packaging and resource data to identify and implement adjustments in the planning and schedules operations and drive operational performance improvements + Identify opportunities for process improvements and implement best practices to enhance production and scheduling efficiency and effectiveness. + Maintain accurate documentation and records for audit purposes. + Provide training, mentoring and development of indirectly reporting employees + All other duties as assigned **The Candidate:** + Requires a Bachelor's Degree; OR Associates Degree with at least 2 years of relevant work experience; OR a High School Diploma/GED with at least 5 years of relevant work experience + Knowledge of production scheduling operations + Fundamental understanding of clinical packaging requirements preferred + High-attention to detail and strong organizational skills + Experience working in an ERP and scheduling system; Orchestrate or JD Edwards preferred + Computer literate (Microsoft Office Suite) + Excellent communication and interpersonal skills + Ability to prioritize and manage multiple projects + Demonstrated indirect leadership and collaboration + Proven ability to adhere to and develop Standard Operating Procedures **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + 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 (*************************************************************************************************************************** .

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Perform a variety of activities related management of study samples including, sample processing, storage, and client support and inventory management. ESSENTIAL DUTIES AND RESPONSIBILITIES:Protocol Interpretation with guidance. Complete Watson inventory training. Perform daily tasks including sample receipt, processing, and storage of samples. Label creation Labelling of collection tubes and/or vials. Train on blood related procedures/techniques. Communicate sample discrepancies with appropriate parties involved within the Test Facility. Maintain blood supply inventory closet. Notify appropriate personnel when supplies require ordering. Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures (SOPs). Assist with appropriate storage placement conditions for all incoming samples per protocol requirements. Clean/Maintain blood processing area including but not limited to centrifuges, countertops, blood processing associated equipment/tools and coolers. Perform data-entry/documentation to maintain accurate status of all sample processing. Retrieve/Restock study materials as needed. Maintain appropriate documentation to demonstrate positive control of study-related materials with guidance. Manage sample processing. Maintain processing records and inventory of required samples per protocol requirements. Complete training requirements as applicable. Perform all other related duties as assigned. The pay range for this position is between $21.00 and $23.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Job Qualifications QUALIFICATIONS: Education: High School Diploma or General Education Degree (G.E.D. or equivalent) required; Associates preferred. GLP experience preferred. Experience: 0-1 years experience in a life science laboratory. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None Other: Must be detailed oriented and have general familiarity with lab procedures. Good verbal and written communication skills required. Basic computer skills; familiarity with Microsoft Office, Excel software and Smartsheets required. Ability to organize and prioritize work and meet timelines efficiently. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231401

Job Title: Compounding Pharmacist Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and Compounding Pharmacist will support the Associate Director of Operations and is responsible for supervising production operations of Compounded Sterile Preparations by implementing and maintaining Sterile Compounding policies/strategies in alignment with all regulatory authorities/guidance's and Hikma Corporate plans and policies. The Compounding Pharmacist will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements. Key Responsibilities: * Ensure adherence to batch records and aseptic techniques. * Monitor Compounding personnel for compliance with gowning, behavior and aseptic technique. * Conduct Investigations for manufacturing deviations. * Execute CAPAs & Change Controls. * Provide Aseptic Training * Provide oversight of compounding and production activities, ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations. * Keep abreast of relevant guidance documents pertaining to 503B production. * Monitor and communicate changes in regulations of all state and federal regulatory agencies. * Assist in new 503B product development, including collaborating on labeling, stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations. * Attain all non-resident Pharmacist licenses within 1 year. * Assist the Associate Director of Compounding Operations in daily oversight of compounding personnel and compounding operations in cleanroom environments. * Review, prepare and approve manufacturing deviations, master batch records and site change controls related to 503B Compounding Operations. * Participate in the administration of Site Projects and New Product Launches to support 503B operations. * Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments. * Provide technical support in the interactions with and applications to state and federal regulatory bodies. * Provide assistance in collection of documents and records regarding state licensing and renewals for state boards of pharmacy. * Assist in writing, review and update of batch records, SOPs, and other cGMP documents. * Maintain current pharmacist licenses in required states, as directed. * Other duties as assigned. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Bachelor of Pharmacy or PharmD required. * State of New Jersey license as a pharmacist is required. Multiple state licenses preferred or ability to obtain state license for the following (AL, AR, ID, KS, MI, MS, NV, NY, OH, OK, KY, VA). * 503B Compounding experience and/or USP 797 knowledge and experience required. * Knowledge of sterile compounding practices. * Knowledge of associated standards and operating procedures in relation to cGMP. * Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.) * A broad perspective to organize objectives, both long-term and day-to-day activities Experience and Skills : * Pharmacist for a 503B outsourcing facility located in New Jersey preferred * New Jersey licensure is required, as well as the ability to obtain multiple state licenses. * Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage. * The ability to change direction and focus to meet shifting organizational and business demands. * The ability to create and contribute to an environment that values people encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. * The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals. * The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity. * The ability to manage multiple resources and be accurate and current with data and information. * Ability to communicate technical information to non-technical personnel Compensation: Base Salary: $ 66,600 to $ 133,750 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia

Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access. Key Responsibilities Strategic CMC Leadership - Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios - Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence - Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions - Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes Cross-Functional Collaboration - Partner with manufacturing, quality, and external organizations to address CMC-related issues - Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers - Support planning and execution of Health Authority meetings, including mock sessions Process Optimization & Innovation - Identify and implement process improvements to enhance regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions - Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer Regulatory Systems & Reporting - Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus - Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & Expertise - 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF) - In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! Skills & Attributes - Strategic and proactive mindset with strong operational execution - Excellent analytical, problem-solving, and negotiation skills - Effective communicator with strong interpersonal, presentation, and leadership abilities - Ability to manage multiple projects independently in a matrixed, multicultural environment - Proficiency in Microsoft Office Suite and regulatory systems Education - Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field - Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred - RAC certification is a plus Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed. \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Title: Project Process Engineer Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project Process Engineer. In this role, you will be responsible for overseeing all project aspects from conception to completion. Activities such as scope development, budgeting, design, procurement, scheduling, construction management, installation, and commissioning will be under your direction. In addition, as you become familiar with the site, you will provide technical expertise to troubleshoot and optimize systems and equipment. In this role, you will focus on projects and engineering support relating to site utilities/infrastructure, facilities, and HVAC. Key Responsibilities: * Building systems and utilities such as site electrical infrastructure, compressed air, plant steam, chilled water, and condenser/tower water. * Critical utilities such as WFI, clean steam, and oil free process air. * Cleanroom HVAC equipment and BMS/BAS control, monitoring, and alarming systems. * A wide variety of facilities projects such as cleanroom construction, facility upgrades, cold storage chambers, stability chambers, warehouse upgrades, office area renovations, etc. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Minimum: B.S. Degree in Engineering and five (5) years of project engineering or maintenance engineering experience. * Strong organizational skills and engineering knowledge. * Excellent communication and time management abilities. * Demonstrated ability to apply project management tools and techniques to engineering projects in multiple disciplines. * Technical investigation and troubleshooting skills especially related to HVAC issues. * Decision making ability and leadership skills. * Working knowledge of cGMPs as they relate to sterile pharmaceutical manufacturing. * Demonstrated knowledge of pharmaceutical manufacturing facilities, critical utilities, and production equipment with respect to their design, installation, and operation. * Strong proficiency with Microsoft Office. * Basic AutoCAD skills. * Experience with Siemens Apogee or Desigo is a plus. * Professional Engineering license or PMP Certification is a plus. Preferred Qualifications: * Preferred: B.S. Degree in Mechanical Engineering and five to fifteen years of project engineering or maintenance engineering experience in the pharmaceutical industry. * Professional Engineering License with HVAC emphasis. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia

+ **Work Schedule:** Monday - Friday, 8:00am - 4:30pm + 100% on-site Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. This position is responsible for being the quality liaison between Philadelphia Quality Assurance and the client. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a Quality relationship. The Quality Program Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels within the organization. **The Role:** + Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests + Plan, schedule, manage, and host customer, corporate, and internal audits. Support regulatory inspections as required + Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions + Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective + Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered + Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff; Act as the primary contact with clients if there are quality questions on documentation, process questions, issues, etc + Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff + Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested + Other duties as assigned **The Candidate:** + Bachelor's degree is required, life sciences or scientific degree is preferred + Five years of relevant experience working in a pharmaceutical industry or life science industry is required + Must possess regulatory and/or client audit experience + Must have the ability to present Quality/ Compliance information both internally at Catalent and externally to clients + Knowledge of cGMP's is required **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 hours of PTO + 8 paid holidays + Generous 401K match + Medical, dental and vision benefits + Tuition Reimbursement - Let us help you finish your degree or start a new degree! **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 (*************************************************************************************************************************** .