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  • Center Manager for Plasma Donation Center

    Grifols 4.2company rating

    Moreno Valley, CA job

    table.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Job Title: CENTER MANAGER Summary: Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation. Works under general occasional guidance and general oversight of regional management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations. Primary Responsibilities for Role: Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals. Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership. Operates the center and manages employees and operations to the highest standard of ethics and integrity. Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency. Directs and manages employees. Monitor and evaluate operations. Develop action plans to maximize center efficiency and supervise the implementation of process improvements. Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to regional management team in advance of cyclical and seasonal or situational spikes. Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records. Provides strategic direction and planning. Other Responsibilities for Role: Acts as a mentor to assigned team, other center staff and other centers. Through Assistant Manager, oversees donor selection, plasma collection and shipment and records completion. Accountable to ensure the adequate training of production employees and demonstrate how tasks are to be performed to meet company standards. Accountable for the adequacy of inventory of all goods and supplies necessary for center operations and oversee ordering goods as needed. Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order. Accountable for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately. Submit timely and accurate reports on a daily/weekly basis or as requested. Develop community representation with regards to all public relations and marketing campaigns to attract and retain donors. Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP). Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP). Directs through the management team and with Training and Quality staff to ensure that training and quality goals are met. Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation. Works with Divisional/Corporate management in the preparation of annual budget and manages facility to consistently achieve production targets and quality goals at the agreed-upon cost structure. Control center donor funds and ensure that all financial records are accurate and in order. Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action. Minimize center liability through constant risk management review. Investigates all unsafe situations and complaints and institutes corrective/preventive action. Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises. Assumes Regional management oversight and mentoring duties for select facilities/projects or in ROMs absence. Performs other duties as required. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Job Requirements: Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field. Typically requires a minimum of 3 years of related work experience in clinical or general business environment. Supervisory experience preferred but not required. Prior management experience, preferably supervising a group of 20 or more employees. Experience in a medical and/or cGMP regulated environment preferred. Experience with plasma or whole blood preferred. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master's degree with 2 years of experience. Attributes: Command of leadership, management, presentation, organizational, customer service, interpersonal communication, and computer skills. Ability to understand, assess and communicate FDA regulations. Ability to balance multiple competing priorities, ensure proper staffing levels, maintain adequate levels of plasma collection, and adhere to quality standards. Ability to control costs and maintain a budget. Ability to motivate staff to achieve established goals and standards. Ability to develop positive relationships with donors, center employees, and company employees working in different geographical locations. Developing command of and proficiency in at least one functional area, such as finance, IT, HR, or compliance. Ability to relocate preferred. Compensation and Benefits: This position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! “We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.” #BiomatUSA #Indeed #app #LI-Onsite #LI-BA1 #LI-RL1 Third Party Agency and Recruiter Notice: Agencies that present a candidate MUST have an active, nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Location: NORTH AMERICA : USA : CA-Moreno Valley Center Address: 718 22nd Ave South, Brookings, SD 57006 Contact: Alex S. Contreras, Senior Talent Acquisition Partner - ************** | ********************** Learn more about Grifols Follow us on Facebook: ******************************************* Follow us on LinkedIn: ***************************************** To find more jobs with Grifols: ******************** Or Text GRIFOLS to ************
    $50k-72k yearly est. 3d ago
  • Visual Inspection and Packing Operator

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA job

    About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Visual Inspection and Packing Operator At Nivagen, the Visual Inspection and Packaging Operator plays a critical role in ensuring product quality and compliance. This position is responsible for conducting manual visual inspections to verify that products meet established quality standards. Additionally, the operator will oversee the operation of leak testing machines and packaging equipment to ensure products are properly prepared for shipment. All tasks must be performed in strict adherence to company protocols and regulatory requirements, maintaining the highest standards of product quality and safety throughout the production process. Responsibilities: To perform the visual inspection of the filled containers i.e., vials (liquid and lyophilized), pre-filled syringes, cartridges and IV bags. To identify the defects i.e., fill volume inconsistencies, glass pieces, metal, colored particles, fibers, cap defects, sealing defects, label flaws, printed text matter flaws, batch coding flaws, wrong labelling, cross labelling flaws etc. and shall ensure no defective product shall be supplied to the market. Segregation of the defects and preparation of defective library and preparation of Knapp kits required for the qualification of automatic inspection machines. Preparation of the documents (including SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment. Responsible for collection, transportation, and storage of the semi-finished products as per product storage conditions. Shall take utmost care to avoid the cross-contamination and mix-up errors. Shall be responsible for the storage of the semi-finished and finished products Collaborate effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands. Qualification/validation of the equipment and area in accordance with approved protocols and preparation and readiness for the routine commercial manufacturing. To perform in process, check and controls in accordance with approved protocols, batch records, SOPs and regulatory guidelines. Collaborate closely with production staff, including operators, supervisors, and quality control teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required. Prepare products for secondary packing using the correct materials and pack them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy. Collaboration with warehouse, production, in-process quality teams for timely support and product deliverables to meet OTIF. Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized. Involved in daily operations, including cleaning, maintaining logs, and overseeing routine packing activities to ensure efficiency and compliance Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences. Inventory management for the consumables required for the day-to-day packing activities. Any other tasks as directed by the supervisor. Education: High school diploma or equivalent required; technical certification or degree in a related field is a plus. Experience: 1-3 years of experience in pharmaceutical manufacturing, visual inspection, or packaging Knowledge and Skills: cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production. Strong attention to detail and ability to detect visual defects. Proficiency in operating inspection and packaging equipment. Ability to follow written instructions and complete documentation accurately. Good communication and teamwork skills. Requirements: Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents) Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Able to successfully complete a drug and background check stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties. Must comply with cleanroom protocols, gowning, and PPE requirements. The role requires strong attention to detail, the ability to identify defects or discrepancies, a basic understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products. Benefits: Pay range $20.0 - $25.0 per hour (Based on Experience) Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
    $20-25 hourly Auto-Apply 50d ago
  • Inventory Specialist

    Knipper 4.5company rating

    San Francisco, CA job

    THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.
    $34k-46k yearly est. Auto-Apply 60d+ ago
  • Neuroscience Specialist - Roseville, CA

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Roseville, CA job

    Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In its evolved customer engagement model, a Neuroscience Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This model enhances patient, caregiver, and HCP experiences by focusing on local care delivery, aiming to improve patient care and provide a superior experience. The Neuroscience Specialist will report directly to the respective Area Business Lead, coordinating with cross-functional colleagues in Medical (MSLs), Market Access (HSAMs), and Patient Support (PELs) under appropriate guidelines. This individual will serve as the primary point of contact for HCP customers and should possess a broad range of expertise, capable of addressing complex on-label information based on approved content. **Position Overview** This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: + Personally engage customers through various virtual or digital tools. + Direct customers to other colleagues, such as Customer Service Specialists (CSS), as needed. + Ensure customer requests are met and solicit feedback on the quality of engagement. + Facilitate speaker programs to share knowledge and insights. + Organize local provider groups for discussions on experiences and outcomes with local/regional leaders. + Elevate opportunities and feedback to the Area Business Lead, including local market insights. + Collaborate compliantly with the ecosystem team to adjust targeting and call point plans. + Action on insights collected from customer-facing roles to inform local strategy and business goals. **Key Responsibilities** + Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. + Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., CSS) as needed. + Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. + Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. **Experience &** **Qualifications** + A minimum of 2 years of pharmaceutical or medical device sales experience. + Must reside within a commutable distance of 50 miles from the primary city in the sales territory. + Previous cross-functional industry experience in commercial life sciences or related industry. + 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. + Ability to work in an ambiguous environment undergoing transformation. + Proven track record in coaching, training, and mentoring peers or others. + Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. + Ability to assimilate and communicate complex clinical and product information. **Key Sales Capabilities** + **Territory Analysis / Business Planning** + Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget + Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan + Responds compliantly to competitive threats and opportunities + Educates office staff on payer guidelines and reimbursement procedures to increase pull through + Effectively utilizes promotional materials + **Selling Skills, Engagement & Account Pull Through** + Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately + Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call + Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders + Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs + Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition \#LI-REMOTE **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,400.00 - Maximum $162,150.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $104.4k yearly 28d ago
  • TS/MS Engineer - Cleaning Validation/Sterilization Validation

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site. Key Objectives / Deliverables: * Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. * Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. * Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc). * Support periodic requalification activities for production equipment and systems. * Author and support the execution of validation protocols and reports. * Provide technical guidance to the Process Team for cleaning and sterilization processes. * Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities. * Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. * Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes. * Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed. * Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc. * Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda. * Serve as cleaning and sterilization interface external to the Concord site. * Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. * Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain. * Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities. Minimum Requirements: * BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline * 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.) Additional Preferences: * In depth knowledge of parenteral drug product manufacturing * Experience executing equipment qualification, cleaning validation, and sterilization validation * Demonstrated successful leadership of cross-functional teams * Experience with data trending and analysis * Ability to analyze complex data and solve problems Other Information: * Role is Monday through Friday based. * Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). * Occasional extended hour and / or off-hour work may be required. * Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites as required Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $66k-171.6k yearly Auto-Apply 45d ago
  • Assembler 2

    Zoetis 4.9company rating

    Union City, CA job

    The Assembler 2 position is responsible for the sub-assembly and packaging of chemistry analysis discs in a clean room environment. SHIFT: 3rd Shift: 9:00 pm - 5:30 am JOB RESPONSIBILITIES: This job description reflects assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Work on the assembly line performing Rotor Production processes such as material handling, packaging, and loading and unloading semi-automated equipment at a fast pace Provide feedback to leads or supervisor when a deviation from accepted practice or safety issue is recognized Reliable inspection of small attributes using magnification ring lamp at a fast pace Follow cGMP, GDP, and safety requirements proficiently Participate in, follow, and provide updates on continuous improvement initiatives (5S, Tier boards, Kaizen, Gemba) Must be certified at bead inspection, weld inspection, and/or the diluent cup set up process Trained on dealing with biohazardous waste within Rotor Manufacturing Perform batch record reviews accurately and with precision Perform basic SAP tasks to review inventory requirements EDUCATION and EXPERIENCE REQUIREMENTS: High school diploma or equivalent (GED) preferred. Experience in a fast-paced environment or in a Medical device company is helpful TECHNICAL SKILLS REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Able to work in a fast-paced environment and perform a variety of functions Strong interpersonal skills and organizational skills, and excellent attention to detail Commitment to follow established policies, practices, procedures. Read, write, and communicate clearly in English to carefully and consistently follow procedures Proficient knowledge of MS office applications Must be certified at bead inspection, weld inspection, and/or the diluent cup set up process Physical Requirements: While performing the duties of this job, incumbent must be able to access all areas of the facility. Will lift 10 lbs. frequently and occasionally lift 50 lbs, and utilize certain Personal Protective Equipment including, but not limited to, hard hats, safety shoes, eye protection, gloves, and/or protective clothing. Availability to work any shift assigned and flexibility to periodically shift schedule start time. The US base salary range for this full-time position is $21.10 - $34.70 Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation. Visit zoetisbenefits.com to learn more. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $21.1-34.7 hourly Auto-Apply 2d ago
  • Director, Trade Operations

    Pacira Pharmaceuticals 4.7company rating

    Brisbane, CA job

    About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together. Summary: The Director, Trade Operations is responsible for leading the strategic and operational execution of Pacira's trade and distribution activities across all channels, including 3PL, wholesalers, specialty distributors, and specialty pharmacies. This role ensures the seamless distribution of Pacira's product portfolio (EXPAREL, ZILRETTA, iovera), oversees chargeback reconciliation, manages trade data and analytics, and drives compliance with regulatory and contractual obligations. The Director will lead a high-performing team and collaborate cross-functionally with Finance, Supply Chain, Market Access, Legal, and Commercial teams to optimize trade operations and support business growth. Responsibilities Essential Duties & Responsibilities: The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. * Develop and execute trade and distribution strategies across all channels. * Lead 3PL operations, including service level agreements, inventory management, and cost optimization. * Manage wholesaler and specialty distributor relationships, including contract execution, pricing notifications, and roster management. * Oversee chargeback reconciliation processes, ensuring accuracy, timeliness, and alignment with contract terms. * Lead the development of trade data analytics and reporting infrastructure to support decision-making and performance tracking. * Ensure compliance with regulatory requirements (e.g., DSCSA, state licensing) and internal quality standards. * Collaborate with cross-functional teams to support product launches, pricing strategy, and supply chain planning. Supervisory Responsibilities: May have lead a team of trade operations professionals Interaction: This position will work closely with internal departments, such as Marketing, Field Sales, Strategic Accounts, Medical Affairs, and with external consultants. Qualifications Education and Experience: * Bachelor's degree in Business, Supply Chain, or related field; MBA preferred. * 8+ years of experience in pharmaceutical trade operations or commercial distribution. * 3+ years of people management experience. * Deep knowledge of pharmaceutical distribution networks, 3PL operations, and chargeback processes. * Experience with ERP systems, EDI data (844/867), and trade data platforms. * Strong analytical, communication, and cross-functional collaboration skills. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knowledge, Skills, and Abilities: * Enjoys working in a fast-paced environment * High levels of organization, attention to detail, and accuracy * Proactively identifies issues and identifies solutions * Acts with urgency and passion, and enjoys helping others * Exceptional interpersonal skills, with a focus on rapport-building, listening, and questioning skills * Interest in infrastructure technology trends and application of technology to improve end user's experience. * Ability to execute assignments within established timeframes and quality standards, while responding to immediate needs Physical Demands: 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: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Benefits Benefits: * Medical, Prescription, Dental, Vision Coverage * Flexible Spending Account & Health Savings Account with Company match * Employee Assistance Program * Mental Health Resources * Disability Coverage * Life insurance * Critical Illness and Accident Insurance * Legal and Identity Theft Protection * Pet Insurance * Fertility and Maternity Assistance * 401(k) with company match * Flexible Time Off (FTO) and 11 paid holidays * Paid Parental Leave Pay Transparency The base pay range for this role is $188,500 to $240,000 The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. EEO Statement EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose. Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
    $188.5k-240k yearly Auto-Apply 30d ago
  • 2026 Summer Intern - Computational Science & Software Test Engineering (CSI)

    Roche 4.7company rating

    Santa Clara, CA job

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. **The Position** **2026** **Summer** **Intern -** **Computational Science & Software Test Engineering (CSI)** _We advance science so that we all have more time with the people we love._ **Department Summary** The Summer at Roche Intern Program has been developed to provide students with a fun yet rewarding summer through hands-on experience. Interns enjoy opportunities to network with other interns as well as employees throughout our organization. Additionally, we help our students meet their career development and educational goals while potentially building a future with the Roche organization. By leveraging the education you have already received, we hope to give you an opportunity to grow and develop with us! **This internship position is located in** **Santa Clara, on-site.** **The Opportunity** + Collaborate with ML Imaging scientists and software engineers/architects to understand the project requirement. + Develop tools that improves the continuous integration and testing of AI/ML algorithms and pipelines. + Learn SAFe software development process and tools. + Breakdown the project requirement to research/technical problems. + Research and communicate/present possible solutions to the problems identified with the team. + Document and create the project report. **Program Highlights** + **Intensive** **12-weeks** **, full-time (40 hours per week) paid internship.** + **Program start dates are in** **May/June 2026.** + **A stipend, based on location, will be provided to help alleviate costs associated with the internship.** + Ownership of challenging and impactful business-critical projects. + Work with some of the most talented people in the biotechnology industry. **Who You Are** **Required Education** You meet one of the following criteria: + Must be pursuing a Bachelor's Degree (enrolled student). + Must be pursuing a Master's Degree (enrolled student). **Required Majors:** Bioinformatics, Biomedical Engineering, Data Science Engineering, Computer Science or Electronics. **Required Skills:** + Good Python programming skills. + Excellent problem-solving and analytical skills. + Experience with version control systems like Git. + Familiarity with software development methodologies and tools. **Preferred Knowledge, Skills, and Qualifications** + Excellent communication, collaboration, and interpersonal skills. + Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. + Proficiency in Python or Java programming languages. + Desired GPA 3.0 or higher. + Previous work experience. + Student organization and/or study abroad experiences. **Relocation benefits are not available for this job posting.** The expected salary range for this position based on the primary location of California is $45.00-$50.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. **Who we are** A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $45-50 hourly 8d ago
  • Operator, Aseptic Filling (Night Shift)

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work a 2-2-3 schedule Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $38k-44k yearly est. Auto-Apply 56d ago
  • Ophthalmics Area Business Lead - US West

    Astellas Pharma 4.9company rating

    San Francisco, CA job

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose: The Area Business Lead (Sales Director) is responsible for providing the leadership necessary to achieve Area level sales goals. This includes sales, sales strategy, resource allocation, and talent development. Today, the Ophthalmic team is focused on maximizing the patient impact and commercial value of IZERVAY. IZERVAY launched in September 2023 and is a complement C5 inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). IZERVAY is a Priority Brand for Astellas and has blockbuster potential. The GA market is a dynamic and rapidly evolving new category of treatment where IZERVAY is one of two options available for treatment. The Area Business Lead is responsible for leading and managing Regional Business Leaders and providing consistent and uniform direction regarding execution of sales and marketing strategies and tactics for Astellas' US products and services. Additional responsibilities include recruiting and development of field force personnel within the geography, including appropriate assessment of performance. This role has oversight and provides direction to optimally allocate key resources and inspire industry leading customer engagement across regional geographies. The ABL is accountable to maintain effective communication and relationships with key external and internal customers and accounts. Essential Job Responsibilities: Demonstrate strong, clear leadership through consistent communication and direction, and assume direct responsibility for achieving sales goals for an assigned therapeutic franchise and geography. Foster a culture of high engagement and accountability by building trust, setting clear expectations, providing coaching and development of managers. Set expectations and high standards of performance for each team member. Accurately assess the team's performance, identify and maximize talents, provide growth and development opportunities, and appropriately allocate rewards/recognition within the Sales Area. Guide and support national/area/regional business strategic plans. Track sales trends and analyze performance to ensure the area meets established goals. Develop and oversee the area's budget, allocating resources effectively. Drive sales effectiveness through execution of marketing and promotional strategies that cater to the special needs of selling in Ophthalmology (specifically) Retina environment. Ensure a high level of collaboration with matrix partners to maximize joint efforts as well as adherence to compliance standards. Work closely with Market Access to establish pull-through programs and take advantage of patient services and favorable Managed Health Care opportunities; ensure excellent coverage and customer service for key accounts in the Sales Area; and assist in ensuring adequate positioning of Astellas' products on key purchasing group's formularies in the nation. Monitor industry trends and competitor activity to guide strategic decision-making. Guide and support sales areas to recruit, train, retain and develop diverse talent to strengthen team capabilities and ensure sustainable performance. Manage and understand trends and human resource needs related to recruitment, performance management, selection, and development. Support and lead development and training initiatives across the region. Represents Astellas' Values and Behaviors by adhering to compliance policies and procedures, while promoting a culture of ethics and integrity. Ensure each Manager and Representative within each region understands, accepts, and adheres to the policies and procedures. Represent sales and collaborate across the brand while building impactful field and marketing strategies ultimately deploying and delivering within area and as needed to national team. Partner and strategize with leadership on executive exchange planning and engagements with priority accounts and/or c-suite and retina community advocates. Carry out additional responsibilities as assigned. Quantitative Dimensions: Responsible for overseeing and leading a sales area inclusive of Regional Business Leaders and Business Specialists. Direct management of Regional Business Leaders (Sales Managers). Directly responsible for providing the leadership and direction for Sales Area to achieve at least 100% goal attainment. High level of skill in developing and maintaining relationships and interacting with internal cross-functional Astellas departments and fostering a cohesive and impactful matrix team to deliver industry leading customer experience and engagement. Engaging external customers, including Key Opinion Leaders and key stakeholders including ECPs and C-Suite within accounts, to better align customer needs to the Astellas organization. Exhibit the leadership qualities and competencies essential for success in a senior leadership role. Organizational Context: Reports into the Ophthalmic Head of Sales. Leads area of regional business leaders and sales representatives.
    $111k-169k yearly est. 5h ago
  • Remediation Deployment Specialist II, Team Lead

    BD Systems 4.5company rating

    San Diego, CA job

    SummaryResponsible for executing field action remediation to include deploying software and firmware remotely, configuring devices in RSS, and performing other remote remediation activities. Requires experience working with customers. Maintains accurate records and documentation on service tickets. Completes service documentation as required. Interface and work closely with advanced support specialists as required. Five to seven years of service experience in the troubleshooting and repair of electronic systems, preferred.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Duration of Employment: This position has a three-year duration, with an anticipated end date of Sept 30, 2028. If at the end of that period you have not been offered or have not accepted another position within BD, your employment will conclude at that time. Job Overview We are seeking a detail-oriented Field Action Remediation Deployment Specialist to implement remote software and firmware deployments, configure devices in RSS, and perform other remediation activities. Additionally, this role will be responsible for leading the team working at night, which includes mentoring other deployment specialists, answering questions, and supporting customer issues that arise. This role requires deep technical skills, excellent customer service abilities, and meticulous documentation practices in an FDA-regulated environment. Key Responsabilities Team Lead Lead and mentor a team of internal and contract Remediation Deployment Specialists Assist with training of new associates Foster a culture of accountability, innovation, and collaboration Additional Responsibilities Complete field action remediation through remote software/firmware deployment Configure devices in RSS and perform other remote remediation activities Maintain accurate records and complete service documentation for all tickets Collaborate with advanced support specialists as needed Build effective working relationships across functions and locations Deliver high-quality work while adhering to strict quality standards Communicate effectively with customers, building rapport and addressing their needs Maintain reporting tools and metric tracking systems with current data Develop and update process documentation Identify workflow improvements and eliminate non-value-added tasks Assist in developing processes and procedures to support department strategies Help draft knowledge articles and job aids Professional Attributes Ability to lead with integrity and motivate a team to deliver results that matter Self-awareness and emotional intelligence in workplace interactions Adaptability in diverse environments Self-starter with curiosity and initiative Problem solver comfortable working in a dynamic, fast paced environment Commitment to broadening skills and supporting organizational capabilities Ability to follow procedures in an FDA-regulated environment Required Qualifications High School Diploma or equivalent experience 3-5 years of proven applied experience Computer Science, Technology, Healthcare-related education or equivalent work experience Proficiency in English (reading, writing, speaking) Deep technical orientation with experience deploying proprietary and standard applications Experience with Windows operating systems, Active Directory, and domain security Analytical skills for logical troubleshooting of technical problems Ability to work independently, manage multiple tasks, and prioritize effectively Problem solver comfortable working in a dynamic, fast paced environment Diligent with thorough follow-up capabilities Goal and action-oriented mentality Comfortable working remotely between 10pm and 6am local time. Minimal weekend/holiday work when necessary. Preferred Qualifications 5-7 years of service experience in troubleshooting and repair of electronic systems Knowledge of cloud computing, SQL, Windows-Unix/Linux environments Prior experience as a team lead or other leadership role Experience with remote access tools and SQL scripting Experience working in FDA-regulated environments At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - San Diego Bldg A&BAdditional LocationsWork ShiftUS BD 3rd Shift 1030pm-630am (United States of America) At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $33.80 - $55.70 USD Hourly
    $33.8-55.7 hourly Auto-Apply 4d ago
  • Senior Manager, CMC Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Sacramento, CA job

    The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $147k yearly 11d ago
  • Caregiver/Med Tech - Assisted Living

    Rose Care Group 4.2company rating

    Arroyo Grande, CA job

    Job DescriptionSalary: $18 - $20 per Hour DOE The primary obligation of the Caregiver/Med Tech is to provide excellent personalized care in regard to assistance with residents activities of daily living (ADLs) to ensure each function at their highest level physically, cognitively, and socially. Direct resident care providers manage care and supervision to residents as needed, and as indicated in the resident care plan. The Caregiver/Med Tech will report to the Wellness Coordinator(s). Duties & Responsibilities: Caregiving Assist residents with activities of daily living such as bathing, grooming, toileting, hygiene, mobility, etc. Assist with incontinent care and adhere to bowel and bladder training as indicated in the residents care plan. Document resident conditions, including input and output, on a daily basis and in a timely manner. Check residents on a regular basis; Observe and report any changes in the residents condition to Wellness Coordinator and follow up with charting. Follow Wellness Coordinator direction regarding residents overall management of care. Monitor resident skin condition, look out for new rashes, skin tears, bruises, patches that are soiled or have come off, etc. Inform the Wellness Coordinator or Director of Wellness of any changes. Document all new skin conditions on residents daily chart. Follow Wellness Coordinator direction regarding residents skin care needs, i.e. prevention techniques such as continuous repositioning, use of heel protectors, etc. Report and document any unusual incidents, such as falls, behaviors, etc. directly to the administrator on duty. Call and inform the administrator on duty in case of emergency. Prepare tables and set up for all meals of the day. Escort residents to dining room. Prepare and deliver tray services if resident is unable to leave room for meals. Assist residents that are not able to eat on their own. Ensure daily laundry is maintained for each resident. Bed linens are done weekly. Ensure that residents rooms are neat, clean, and orderly. Maintain cleanliness in all common areas, living rooms, kitchens, dining areas, courtyard, activity room, beauty salon etc. Follow Wellness Coordinator direction regarding cleaning schedules and procedures. Ensure that residents are informed and may attend planned activities in the common activity areas. Spend quality time with residents, i.e. visiting residents in their room, painting nails, going on walks, outside fun, afternoon snacks & bingo etc. We are here to serve our residents; their happiness and health is our number one priority. Adhere to all safety rules and practices. Attend all regular safety, staff, and training meetings. These meetings are mandatory and failure to attend can lead to an unexcused absence. Maintain online state mandated annual caregiver training. Maintain work accounts and communication. Keep Wellness Coordinator up to date on all important matters regarding resident overall change in condition. Other duties as assigned for the operation of the company, or resident need and safety. Medication Management Administer medication directly to residents as prescribed. Supervise residents to ensure medications are taken. Document medications administered to residents on residents MARS, including medication refusal, medication holds, etc Reorder medications in a timely manner, i.e. PRN medication, narcotic medications that are not part of the monthly cycle. Record newly delivered medication on centrally stored medication logs, maintaining an accurate LIC 622. Maintain signed and updated Medication Verification Lists for each resident, i.e. residents file and emergency envelope. Keep emergency envelopes updated and maintain two copies for each resident. Maintain copies of all physician orders. Manage medication records, i.e. medication verification list, centrally stored medication record, PRN letters, and MARS for all incoming residents. Monitor residents for change of condition and communicate changes and concerns to the appropriate health care provider. Requesting specific orders, medication changes etc. Documents all changes in residents medication records. Maintain all State mandated medication training records annually. NOC Shift Specific: Wellness check at beginning of shift - check in with exiting caregiver to receive update/current status on each resident. Perform wellness check on each resident, ensuring that residents are present and well. Assist residents in night routine, i.e. tuck in routine, brushing teeth, putting on pajamas, etc. Perform bedtime medpass and continuously monitor residents throughout NOC shift, providing PRN medicine as needed. Throughout shift, check each resident every two hours Required Experience, Education, & Skills: To be able to stand for extended periods of time, bend, climb stairs, reach & grasp. Be able to respond to pagers and radios. Must be reliable, responsible, timely, efficient, well-organized, and have a strong attention to detail Excellent prioritization and time management skills, and ability to multitask Strong communication skills to work well with the Wellness Coordinator, peer staff, clients, and families Approachable, professional presentation and attitude; always willing to help and lead other caregivers to go the extra mile. Promote a team spirit and a can do attitude Deal with reasonable complaints/requests with professionalism and patience Ability to work with little supervision and maintain a high level of performance Customer-oriented and friendly Working quickly without compromising quality Knowledge of English language: able to read, write, and converse Abide by all RCG policies and procedures, including but not limited to cell phone use, privacy, uniform guidelines and professional appearance, personal conduct and residents rights Complete all required initial and scheduled training on time and with a passing score/meets expectations Work effectively individually and in a team environment. Able to perform the essential functions of the job with or without reasonable accommodations. About Rose Care Group: Rose care Group is a leading provider of comprehensive, compassionate, and personalized residential care services for the elderly in San Luis Obispo, California. Our dedicated team works tirelessly to create a comfortable, safe, and nurturing environment for our residents, ensuring that they receive the highest level of care and support.
    $18-20 hourly 4d ago
  • Inventory Specialist

    Knipper 4.5company rating

    San Jose, CA job

    THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.
    $34k-47k yearly est. Auto-Apply 60d+ ago
  • Director, Technical Operations

    Charles River Laboratories 4.3company rating

    Los Angeles, CA job

    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** The Director, Technical Operations is primarily responsible for providing technical oversight for operations functions within the organization. The Director, Technical Operations works closely with the Medical Office in establishing donor safety as the highest priority for Cell Solutions and has oversight of the Donor center operations. This role also works very closely with the Commercial Team to support new and existing revenue growth opportunities, feasibility on custom projects, technical operations and serving as a Subject Matter Expert (SME) for human starting materials procurement in support of cell and gene therapy clients. As the SME for Technical Operations, the Director is responsible for ensuring compliance of all technical operations with applicable Standard Operating Procedures (SOPs), review of Quality Agreements, MSAs and SOWs for Commercial Team, regulatory agencies, and industry best practices. Essential Responsibilities + Provides technical oversight of the HemaCare Donor Center (main areas of donor operations and donor recruitment) + Establishes with the guidance of the CS Medical Director(s) the Donor Center operations best practices and adjustments needed to meet regulatory requirements and also to best support commercial revenue generation. + In alignment with strategic goals and planning, plays a critical sponsorship role in multiple complex projects to drive revenue growth initiatives (eg. Donor Room Operations/ Donor Base Optimization, Technical Operations, custom projects), working with Cell Solutions PMO office as needed, to ensure capabilities and resourcing meets client demands and leads the market and competition. + Serves on the Senior Leadership Team meetings to help set technical operations priorities and focus for Cell Solutions. + Ensures that all departments supervised provide high-quality customer service, follow safety guidelines and perform tasks in compliance with the company's quality program, SOPs, current Good Manufacturing Practices ('cGMP') and regulatory agencies and AABB guidelines. + Reports and investigate incidents, variances and complaints as outlined in the appropriate SOPs. + Supports customer and regulatory audits. Reviews and approves error/accident reports, all related root cause analysis, corrective actions, preventive action and follow-up. Provide appropriate guidance, direction and training to ensure effective resolutions. + Responsible, in collaboration with the Director, Manufacturing Operations, to ensure proper staffing capacity to fulfill on-going production needs resulting in timely revenue generation. + Develops and manages budget and resources for departments under his/her control. + Generates and analyzes reports regarding technical functions and KPIs. + Develops production/service or operations and resource plans that meet goals in terms of safety, quality, output, and cost. + Applies all applicable OSHA and related local safety requirements to all assigned work and ensures that the facility is within OSHA compliance + Perform additional duties as assigned **Job Qualifications** To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Experience with current Good Manufacturing Practices (cGMP's), current Good Tissue Practice (cGTP's), 1271 CFR, FDA and E.U. cell therapy requirements. + 5+ years' expertise in industry standard blood donor center operations including leukapheresis platforms preferred. + 5+ years' or more experience in revenue growth opportunities support with cell and gene therapy clients. + 5+ years' experience building relationships with various customers within academic, biotechnology, and/or pharmaceutical organizations. Education, Experience, and Licensure + Minimum Bachelor's Degree in Biological, Chemical, Physical, or Medical Technology or Clinical Laboratory Science, or other technical field, or equivalent education and experience. + Blood collection/banking experience is highly desirable. Technical Sales experience is a bonus. Compensation Data The pay range for this position is $190,000 - $210,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **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 Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. 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 *************** 230404
    $190k-210k yearly Easy Apply 60d+ ago
  • Clinical Field Specialist (San Diego)

    BD Systems 4.5company rating

    San Diego, CA job

    SummaryA Day in the Life: The Clinical Field Specialist will provide education on products within the Advanced Patient Monitoring portfolio through intra-operative case coverage, coordinating one-on-one ad hoc training sessions and in-service education programs in the ICU, OR, and other acute care areas. They will also provide physicians and medical staff with clinical instructions to ensure continuity of education and technical support related to all aspects of patient outcome throughout continuum of care while anticipating and foreseeing obstacles and planning accordingly for smooth execution. We expect our CFS to advocate with clinicians to uncover other opportunities to expand the use for Advanced Patient Monitoring products. One way they have found success is by, identifying and training select hospital staff members to act as designated guide on BD products. None of this can be done, without collaborating with sales reps and managers to implement a strategic plan of action in their respective territory! Lastly, this person will be responsible for validating software and hardware updates in the field as applicable. This position requires travel through the Arizona territory. We are looking for someone who lives in this region.Job DescriptionWe are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. This territory will cover the entire state of Arizona. This position requires travel through the San Diego, CA territory. We are looking for someone who lives in this region. What you will need (Required): Minimum of 3 years of previous clinical experience in an acute care environment Associate's degree or equivalent experience in Nursing or clinical field Proven understanding of cardiovascular science, cardiovascular anatomy, pathology and physiology What else we look for (Preferred): Bachelor's degree or equivalent experience Critical Care and/or Cardiac Clinical Experience - TVC, CV ICU or CV OR nursing experience highly preferred Licensed as a Registered Nurse Strong understanding of hemodynamic monitoring Proven ability to inspire change within their hospital/organization At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift
    $48k-79k yearly est. Auto-Apply 60d+ ago
  • Operator, Aseptic Filling (Day Shift)

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work 6am to 6pm on a 2-2-3 schedule * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $38k-44k yearly est. Auto-Apply 60d+ ago
  • IT Specialist

    Pyramid Laboratories 3.6company rating

    Costa Mesa, CA job

    The IT Specialist is responsible for providing technical support, system administration, and infrastructure maintenance in a GMP-compliant pharmaceutical CDMO environment. This role ensures the secure, reliable, and compliant operation of all IT systems, networks, and applications that support manufacturing, laboratory, and business operations. The IT Specialist will collaborate closely with Quality Assurance, Production, and R&D to ensure all IT solutions meet both operational needs and regulatory requirements. Key Responsibilities 1. Technical Support & Troubleshooting Provide timely end-user support for hardware, software, and network issues. Diagnose, troubleshoot, and resolve incidents via phone, email, remote tools, and in person. Escalate complex issues to senior IT staff or vendors as necessary. 2. System Administration Install, configure, and maintain workstations, servers, printers, and mobile devices. Administer Active Directory, email systems, user accounts, and permissions. Manage and maintain data backup, disaster recovery, and storage solutions. 3. GMP & Regulatory Compliance Ensure all IT systems and processes comply with GMP, FDA, and other applicable regulatory guidelines. Support Computer System Validation (CSV) activities, including documentation, change control, and periodic reviews. Maintain detailed records of system configurations, updates, and incidents in compliance with audit requirements. 4. Network & Security Monitor and maintain LAN/WAN, wireless networks, and internet connectivity. Apply security updates, patches, and antivirus protection. Assist in implementing cybersecurity best practices and incident response procedures. 5. Collaboration & Projects Partner with cross-functional teams to support IT requirements for manufacturing, laboratory, and administrative operations. Assist in planning and executing IT infrastructure upgrades, migrations, and implementations. Provide technical input during audits, inspections, and customer visits as needed. Qualifications Education & Experience: Associate's or Bachelor's degree in Information Technology, Computer Science, or related field preferred. 2+ years of experience in IT support or system administration, preferably in a pharmaceutical, biotech, or GMP-regulated environment. Skills & Competencies: Strong knowledge of Windows operating systems, Microsoft 365, and networking fundamentals. Experience with Active Directory, file permissions, and group policies. Familiarity with ERP, LIMS, MES, or other laboratory/manufacturing systems (preferred). Understanding of GMP, 21 CFR Part 11, and data integrity requirements (preferred). Excellent troubleshooting, communication, and customer service skills. Ability to handle multiple priorities in a fast-paced, regulated environment. Preferred Certifications: CompTIA A+ (IT support fundamentals) CompTIA Network+ (networking basics) HDI Support Center Analyst (HDI-SCA) or HDI Desktop Support Technician (HDI-DST) Microsoft Certified: Modern Desktop Administrator Associate ITIL Foundation (IT service management best practices) Physical Requirements Ability to lift up to 25 lbs. for equipment installation. Ability to sit or stand for extended periods. Occasional after-hours or weekend work to support system maintenance or project deadlines. Work Environment Office and manufacturing/laboratory settings with exposure to cleanroom environments. Strict adherence to company safety, security, and GMP policies is required.
    $68k-99k yearly est. Auto-Apply 60d+ ago
  • Senior Director, Strategy & Analysis, Contract Operations

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Sacramento, CA job

    The Senior Director, Strategy & Analysis; Contract Operations works cross-functionally to develop and execute pricing strategies for pipeline and in-market products and manages contract operations to optimize revenue, market share, and support patient access. Leads and conducts pricing analysis of current and proposed governmental policies with respect to impact on pipeline and in-market portfolio products. In addition, this role is responsible for implementing and evolving contract operations to support the company's market access strategy. Leads an operations team and third-party vendor in executing rebate invoice validation and payment, Gross to Net (GTN) forecasting, and government price reporting. Leads team to accomplish business objectives while ensuring compliance with all relevant policies and procedures. **Strategy & Analysis:** Supports development of market access strategies for in-market and pipeline products. Works cross-functionally to develop pricing and associated contracting strategies for pipeline and in-market products. Partners with Insights & Analytics team to assess impact of payer access controls and price on in-market and pipeline products. Works closely with Government Affairs to model/assess policy scenarios and evaluate the financial impact to Otsuka for both in-market and pipeline products. **Contract Operations:** Implements and evolves contract operations to support the company's market access strategy. Oversees rebate invoice processing including validation to prevent revenue leakage and payment processes. Includes oversight of third-party vendor supporting the process. Oversees Government Pricing operations including the third-party vendor to ensure all calculations and processes are performed according to approved policy and procedures. This includes ensuring accurate reporting and timely internal communications to ensure alignment. Ensures all deadlines are met and delivers effective overall operations. Oversees the process and third-party vendor for State Price Transparency Reporting. This includes establishing a process for monitoring state requirements, proactively identifying Otsuka's requirements, and leading the development of reports through the approval and submission process, informing leadership of relevant changes with recommendations regarding Otsuka's actions. Ensures accurate and timely report submissions and maintenance of historical records. Leads review of Government Pricing policy, SOP's and SOX compliance documents on an on-going basis and updates as necessary. Oversees GTN forecasting in support of budget and forecast processes as well as assessments of strategic scenarios to determine impact on GTN; recommends optimal GTN approach. Establishes KPIs to assess efficiency and impact of operations. **People Management:** Leads a team to achieve agreed to goals, while ensuring compliance with regulations and policies. Develops and improves team skill sets through formalized training as well as through formal and informal feedback; ensures team is receiving continuing education in customer and market knowledge. Supports team members in career development and establishes a succession plan. **Ethics and Compliance:** · Ensures compliance with all applicable policies and ensures those around him/her do the same. **Qualifications** **Skills and Experience:** + A minimum of 10+ years of pharmaceutical industry, Market Access, or payer experience + Thorough understanding and knowledge of US healthcare economics and the drivers of pharmaceutical demand, including pricing and reimbursement + Deep understanding of US pharmaceutical value chain and its business processes + Extensive experience in healthcare contracting and in-depth understanding of GPO/PBM/National and Regional Health Plan business models, Medicare Part D, Medicare Part B, 340B, and the changing market landscape + In-depth knowledge of patient access, launch excellence, marketing and business processes + Strong government pricing knowledge and experience + Strong financial acumen, forecasting, and modeling abilities + Proven ability to navigate complex customer contract negotiations + Ability to drive cross-functional collaboration and strategic alignment across multiple teams + Excellent communication and executive presentation skills + Demonstrated ability to create solutions for complex processes and procedures + Inspirational leadership ability including a high level of self-awareness and curiosity as well as a focus on empowering others + Demonstrates high degree of emotional intelligence, adaptability, and creativity in solution-oriented ideation - results-oriented, fails fast to learn faster, and embodies an agile, growth mindset + Proficient in Microsoft Office, particularly Excel and PowerPoint **Education:** Bachelor's degree or equivalent education/degree required, MBA or equivalent preferred **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $205.4k yearly 22d ago
  • Inventory Specialist

    Knipper 4.5company rating

    Clovis, CA job

    THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.
    $34k-46k yearly est. Auto-Apply 60d+ ago

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