Senior Manufacturing Associate

Overview

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.

Company Overview

Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. 

Job Description

Manufacturing Senior Associate

Department:  Internal Manufacturing

Location:  Thousand Oaks, CA

Reports To:  Manufacturing Supervisor

 

SUMMARY OF 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.

 

MAJOR ACTIVITIES AND 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 

 

BACKGROUND REQUIREMENTS (Education, Behavioral, Professional & Technical Capabilities Experience):

 

QUALIFICATIONS:

• 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

 

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 cle