The Senior Manufacturing Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance. This role contributes to the successful delivery of released product in support of clinical trials and commercial production.
Company OverviewAt FUJIFILM Biotechnologies California, we’re driving the future of medicine with the expertise to produce life-changing cell therapies like T-cell and CAR T immunotherapies. Working with pioneering biotech partners, our teams manufacture innovative treatments that improve lives.
Join us at our advanced Thousand Oaks facility, where you’ll make a tangible impact on groundbreaking therapies. We offer a collaborative, flexible workplace and a vibrant culture driven by passion and energy—what we call Genki. If you’re ready to reimagine the future of healthcare, let’s create something extraordinary together.
Our campus is in Thousand Oaks, California, an exceptional place to live with great schools, natural beauty, outdoor activities, and proximity to Los Angeles and Santa Barbara.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers
Job DescriptionResponsibilities:
Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operationSupport production in a controlled environment and train staff as neededUnder minimum supervision, executes on production batch records and according to standard operating procedures and protocolsUnder minimum supervision, assist in all areas of cell processing and all related duties as required including (stocking, inventory management, material movement and reconciliation, controlled forms management, planner entry form issuance and other tasksIndependently support manufacturing batch record reviewAssists in the development of manufacturing electronic batch recordsAuthor drafts and revision of standard operating procedures, /work instructions/batch records of existing and new processes and or equipment as neededSupport routine maintenance and cleaning of rooms and equipmentPerform tasks in a manner consistent with the safety policies, quality systems, and GMP requirementsInitiate Work orders as neededIndependently supports initiation and investigation of minor deviations and supports root cause investigations and CAPA recordsSupport as SME training of staff as applicableIdentifies and implements continuous improvementsSupport NPI and Process Transfer activities as neededExecute visual inspection of final drug product.Will be managing D space during production (sample handoff, material ingress as needed, print documents as needed).Assist the team with maintaining an up-to-date working inventory for the equipment/suppliesDocument and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, to include electronic documentationParticipate in a detailed training program and develop training planPerform tasks in a manner consistent with the safety policies, quality systems, and GMP requirementsQualifications:
Bachelor of Science (B.Sc.) with 2 + years of applicable biopharma experience or Associate degree with 4+ years of applicable biopharma experience or High school diploma with 7+ years of applicable biopharma experiencePreferred Skills:
Understanding of Aseptic Behaviors / TechniquesExperience in biomanufacturing environmentsAbility to follow verbal and written instructionsProblem solving skillsDetail orientedTeam playerAbility to work with minimal supervisionStrong communication skillsWork Environment:
Work is generally performed in a Good Manufacturing Practice (GMP) facility. A GMP facility is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area:Makeup, painted nails or Hair products (spray, gel, wax)Perfume and cologneJewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/ear piercings, etc.)Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environmentPersonal Protective Equipment is required to perform certain tasks (i.e., latex/nitrile gloves, respirators and or masks, goggles, plant dedicated scrubs/shoes, full body gown that covers all exposed skin)Subject to extended periods of standing, to include crouching / kneeling (8 plus hours) while being donned in applicable PPERequired to handle biohazardous and hazardous material via direction of Standard Operating ProceduresPhysical Requirements:
Medium work that includes moving, lifting, pushing and or pulling objects up to 50 pounds.Medium work that includes pushing and or pulling equipment with up to 50 pounds of force assisted by wheels.Must be willing and able to bend, stoop, squat, crawl, twist, climb ladders, and wear a respiratorPosition requires a combination of standing in the manufacturing environment and walking around the facility.Open to work various shifts as neededRequired to work weekends and holidaysSalary and Benefits:
For California, the base salary range for this position is $34.50-42.50 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).Medical, Dental, VisionLife Insurance401kPaid Time OffLI-#Onsite
EEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).
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