Position Overview
The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.
Company Overview
At FUJIFILM Diosynth 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 Description
Reports to: Manufacturing Supervisor
Function: Technical Operations (Manufacturing)
Location: Thousand Oaks, CA
SUMMARY OF POSITION:
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.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
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 all related duties as required including (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 the safety policies, quality systems, and GMP
Adhere to all safety protocols and procedures.
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
Maintain inventory of equipment and supplies
Identifies and implements continuous improvements
Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
Adhere to all safety protocols and procedures
BACKGROUND REQUIREMENTS (Education, Behavioral, Professional & Technical Capabilities Experience):
Qualifications
Bachelor of Science (B.Sc.) with 0-3 years of applicable biopharma experience; or
Associate degree with 2+ years of applicable biopharma experience; or
High school diploma with 3+ years of applicable biopharma experience
Preferred Qualifications
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 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
Hair products (spray, gel, wax)
Perfume and cologne
Jewelry (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 environment
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)
Subject to extended periods of standing, to include crouching / kneeling (8 plus hours) while being donned in applicable PPE
Required to handle biohazardous and hazardous material via direction of Standard Operating Procedures
PHYSICAL 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 respirator
Position requires a combination of standing in the manufacturing environment and walking around the facility
Open to work various shifts as needed
Required to work weekends and holidays
SALARY AND BENEFITS:
$29.50 to $33.50 per hour, depending on experience
Medical, Dental and Vision
Life Insurance
401k
Paid Time Off
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
*#LI-Onsite
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 (FDBCHR@fujifilm.com).
Job Locations US-CA-Thousand Oaks
Posted Date 14 hours ago (5/19/2025 9:15 AM)
Requisition ID 2025-33740
Category Manufacturing
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
