Senior Manufacturing Associate

Fujifilm•Thousand Oaks, CA

2d•$35 - $43•Onsite

About The Position

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 Overview At 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

Requirements

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 experience

Nice To Haves

Understanding of Aseptic Behaviors / Techniques
Experience in biomanufacturing environments
Ability to follow verbal and written instructions
Problem solving skills
Detail oriented
Team player
Ability to work with minimal supervision
Strong communication skills

Responsibilities

Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operation
Support production in a controlled environment and train staff as needed
Under minimum supervision, executes on production batch records and according to standard operating procedures and protocols
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
Independently support manufacturing batch record review
Assists in the development of manufacturing electronic batch records
Author drafts and revision of standard operating procedures, /work instructions/batch records of existing and new processes and or equipment as needed
Support routine maintenance and cleaning of rooms and equipment
Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
Initiate Work orders as needed
Independently supports initiation and investigation of minor deviations and supports root cause investigations and CAPA records
Support as SME training of staff as applicable
Identifies and implements continuous improvements
Support NPI and Process Transfer activities as needed
Execute 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/supplies
Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, to include electronic documentation
Participate in a detailed training program and develop training plan
Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements