POSITION DESCRIPTION:  Fill Finish Operations Group Lead

We are looking for an experienced manufacturing professional to join the team at Adaptive Phage Therapeutics (APT) as a Fill Finish Operations Group Lead. In this position, the Group Lead will be responsible for a Fill Finish team operating in a GMP cleanroom environment.  The team will be responsible for the manufacture and QC check of an injectable biologic drug substance into ready to use vials (finished drug product).  

Major Responsibilities:

  • Leads processes for the manufacture of the Finished Drug Product under approved standard operating procedures (SOPs).  
  • Adheres to the company Quality Management System (QMS) to maintain highly controlled manufacturing process. 
  • Schedules personnel for fill finish operations, oversees management of related inventory supply and maintaining/review of detailed manufacturing batch records.
  • Responsible for training of new personnel on established SOPs and related manufacturing processes.
  • Composes, edits, and maintains SOPs of manufacturing processes
  • Adheres to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Biological Safety Level-2 (BSL-2), and strict aseptic technique in all manufacturing/Laboratory processes.
  • Maintains a clean working environment including participation in regular laboratory cleaning schedule per established cleaning SOPs.

Job requirements:

  • BS in biology, chemistry, engineering, or related field.
  • 5+ years of experience in GMP bioprocessing/manufacturing in cleanroom environments.
  • Experience operating automated filling instruments is highly desired.
  • Experience filling IV grade material required
  • Experience handling biologics is a plus.
  • Familiar with electronic batch record and document control systems
  • Experience planning, writing, and executing validations protocols for process and equipment preferred.
  • Candidate must have outstanding organizational and communication skills.
  • Have experience working in a manufacturing team environment.
  • Must be able to lift 40 lbs.
  • ¬†Must be able to stand and work for extended periods of time.
  • Will require scheduling flexibility to accommodate varying manufacturing schedules. Weekend shifts are also possible.¬†

Compensation:  Salary is industry-standard and is commensurate with experience.

To apply:  Please email cover letter and resume to [email protected]

Job ID: 21.002