Manufacturing Associate

The 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.

FUJIFILM Biotechnologies California manufactures innovative cell therapies like T-cell and CAR T immunotherapies. Join us at our Thousand Oaks facility, where you’ll make a tangible impact on groundbreaking therapies in a collaborative, flexible workplace with a culture we call Genki. Our campus is in Thousand Oaks, California, near Los Angeles and Santa Barbara. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments.

We are guided by our Group Purpose of “giving our world more smiles.”

• Performs Aseptic operations in a Grade A environment
• Support production in an aseptic environment
• Executes on production batch records and work orders according to SOPs and protocols
• Generates work orders
• Assist in all areas of cell therapy and related duties (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects)
• Assists in manufacturing batch record review
• With supervision, initiates deviations and participates in root cause investigations and CAPA
• Drafts and revises SOPs/WINs/BRs
• Execute SAP transactions
• Execute media batching
• Routine maintenance and cleaning of rooms and equipment
• Identifies and implements continuous improvements
• Perform tasks in a manner consistent with safety policies, quality systems, and GMP
• Adhere to all safety protocols and procedures
• Execute visual inspection of final drug product
• Manage 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 equipment and supplies
• Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, including electronic documentation
• Participate in a detailed training program and develop a training plan
• Maintain inventory of equipment and supplies
• Identify and implement continuous improvements
• Perform tasks in a manner consistent with safety policies, quality systems, and GMP requirements
• Adhere to all safety protocols and procedures

• Bachelor’s Degree in science-based discipline; or Associate degree with 2+ years of applicable biopharma cell therapy or cell culture experience; or High school diploma with 5+ years of applicable biopharma cell therapy or cell culture experience
• Relevant technical writing experience with Biopharma SOPs or applicable academic materials (e.g., reports, papers, essays)

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

• Work is generally performed in a Good Manufacturing Practice (GMP) facility with hygiene and clothing requirements
• Restricted items in GMP areas include makeup, painted nails, hair products, perfume/cologne, jewelry, etc.
• Donning gowns requires ability to physically don gowns in a cleanroom
• Personal Protective Equipment is required for certain tasks
• Extended periods of standing (8+ hours) in PPE
• Handle biohazardous and hazardous material as directed by SOPs

• Medium work, including moving, lifting, pushing, and pulling up to 50 pounds
• Ability to push/pull equipment up to 50 pounds with wheels
• Willingness to bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
• Combination of standing and walking in the manufacturing environment
• Open to varying shifts as needed
• Required to work weekends and holidays

• For California, base salary range is $ per hour; compensation depends on qualifications, education, experience, location, etc.
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

Fujifilm is committed to equal opportunity in hiring, promotion, advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or participating in the selection process, please direct inquiries to our HR Department ().