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