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).
- 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.
- 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