Manufacturing Senior Associate

Overview

 Join us!  FDB 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.  The Sr. Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and continuous improvements.  This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

External US

 

 

Senior Manufacturing Associate

 

The Sr. Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and continuous improvements.  This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

 

Location:  Thousand Oaks

Reports To:  Manufacturing Supervisor

 

Primary 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
• Identifies and implements continuous improvements
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
• Support training of staff as need
• Initiate Work orders as needed
• Independently supports initiation and investigation of minor deviations
• Support as SME training of staff as applicable
• Maintain inventory of equipment and supplies
• Support Process improvements and Process Transfer activities as needed
• Initiates deviations and participates in root cause investigations and CAPA
• Assists in the development of manufacturing electronic batch records

 

Qualifications:

• Bachelor of Science (B.Sc.) with 3+ years of experience; or
• Associate degree with 4+ years of experience; or 
• High school diploma with 5+ years of 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
• Strong demonstrated aseptic techniques

 

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

 

Essential Physical Requirements:

• 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
• Requir