Senior Manufacturing Associate

Fujifilm • Thousand Oaks, CA

86d • $34 - $42

About The Position

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.

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

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Machinery Manufacturing
• Education Level: Bachelor's degree