Manufacturing Associate

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Manufacturing Associate will report directly to the Manufacturing Supervisor at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for supporting production in an aseptic environment. They will execute on production batch records and work orders according to SOPs and protocols.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

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.

Reports to: Manufacturing Supervisor

Function: Technical Operations (Manufacturing)

Location: Thousand Oaks, CA

Schedule: Wednesday through Saturday

Primary 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
• Assist in all areas of cell culture 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
• Initiates deviations and participates in root cause investigations and CAPA
• Assists in the development of manufacturing electronic batch records.
• Drafts and revises SOPs/ WINs/ BRs
• 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 requirements
• Adhere to all safety protocols and procedures

Education and Professional Experience:

• Bachelor of Science (B.Sc.) with 0-3 years of experience; or Associate degree with 2+ years of experience; or High school diploma with 3+ years of experience

Position Requirements

• cGMP knowledge
• Basic knowledge of aseptic processing
• Basic knowledge of cell culture (preferred)
• Ability to follow verbal and written instructions
• Problem Solving skills
• Detail oriented
• Team player
• Strong communication skills
• Strong demonstrated aseptic techniques

Salary and Benefits:

• $28 to $32 per hour, depending on experience.
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off