Senior Manufacturing Associate

Position Overview The Manufacturing Senior 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 Overview At FUJIFILM Biotechnologies California, weu2019re 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 youu2019ll make a tangible impact on groundbreaking therapies. We offer a collaborative, flexible workplace and a vibrant culture driven by passion and energyu2014what we call Genki. If youu2019re ready to reimagine the future of healthcare, letu2019s 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 u201cgiving our world more smiles.u201d Visit: Job Description RESPONSIBILITIES: u2022 Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operation u2022 Support production in a controlled environment and train staff as needed u2022 Under minimum supervision, executes on production batch records and according to standard operating procedures and protocols u2022 Under 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 tasks u2022 Independently support manufacturing batch record review u2022 Assists in the development of manufacturing electronic batch records u2022 Author drafts and revision of standard operating procedures, /work instructions/batch records of existing and new processes and or equipment as needed u2022 Support routine maintenance and cleaning of rooms and equipment u2022 Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements u2022 Initiate Work orders as needed u2022 Independently supports initiation and investigation of minor deviations and supports root cause investigations and CAPA records u2022 Support as SME training of staff as applicable u2022 Identifies and implements continuous improvements u2022 Support NPI and Process Transfer activities as needed u2022 Execute visual inspection of final drug product. u2022 Will be managing D space during production (sample handoff, material ingress as needed, print documents as needed). u2022 Assist the team with maintaining an up-to-date working inventory for the equipment/supplies u2022 Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, to include electronic documentation u2022 Participate in a detailed training program and develop training plan u2022 Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements Qualifications: u2022 Bachelor of Science (B.Sc.) with 2 + years of applicable biopharma experience orAssociate degree with 4+ years of applicable biopharma experience orHigh school diploma with 7+ years of applicable biopharma experience Preferred Skills: u2022 Understanding of Aseptic Behaviors / Techniques u2022 Experience in biomanufacturing environments Ability to follow verbal and written instructions u2022 Problem solving skills u2022 Detail oriented u2022 Team player u2022 Ability to work with minimal supervision u2022 Strong communication skills WORK ENVIRONMENT: u2022 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 cologne + Jewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/ear piercings, etc.) u2022 Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment u2022 Personal 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) u2022 Subject to extended periods of standing, to include crouching / kneeling (8 plus hours) while being donned in applicable PPE u2022 Required to handle biohazardous and hazardous material via direction of Standard Operating Procedures PHYSICAL REQUIREMENTS: u2022 Medium work that includes moving, lifting, pushing and or pulling objects up to 50 pounds. u2022 Medium work that includes pushing and or pulling equipment with up to 50 pounds of force assisted by wheels. u2022 Must be willing and able to bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator u2022 Position requires a combination of standing in the manufacturing environment and walking around the facility. u2022 Open to work various shifts as needed u2022 Required to work weekends and holidays Salary 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, Vision + Life Insurance + 401k + Paid Time Off EEO Information Fujifilm 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 Information If 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 (). Job Locations _US-CA-Thousand Oaks_ Posted Date _8 hours ago_ _(10/7/2025 5:21 PM)_ _Requisition ID_ _2025-35641_ _Category_ _Manufacturing_ _Company (Portal Searching)_ _FUJIFILM Biotechnologies_

Created: 2025-10-09