Position Description: Microbiologist I/II – Quality Control Testing
Exciting opportunity for an experienced microbiologist/phage biologist to join the upstream manufacturing team at Adaptive Phage Therapeutics (APT). In this position, the candidate will support day-to-day operations to ensure timely and accurate testing of materials and products while maintaining quality and compliance to meet the demands of manufacturing.
- Support manufacturing operations by; including but not limited to process validation, environmental monitoring, and utility systems sampling and testing.
- Receive, archive and process clinical trial specimens according to company SOPs.
- Perform in-house microbiological assays for manufactured material and/or clinical trial samples.
- Prepare analytical lab reports or summaries as required within the necessary timeframe.
- Write, revise, and review SOPs for compliance with respective compendia, equipment operation, methods, and general laboratory procedures as needed.
- Perform in-process testing of material prior to releasing to downstream manufacturing team(s).
- Perform processes for the manufacture of the therapeutic product(s) under approved Standard Operating Procedures (SOPs).
- Adhere to the company Quality Management System (QMS) to maintain highly controlled manufacturing processes.
- Adhere to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Biological Safety Level-2 (BSL-2), and aseptic technique in all Manufacturing/Laboratory processes.
- Perform QC testing of the therapeutic product per regulatory guidelines and/or SOPs.
- Must maintain a clean working environment including participation in regular laboratory cleaning schedule per established cleaning SOPs.
- Perform routine quality control review of manufacturing documents to comply with documentation practices outlined in the FDA’s guidance’s for Phase 1 GMP’s. These documents including but are not limited to: SOPs, Batch Records, Forms and third-party testing reports.
- Help provide oversight of day to day record-keeping, reporting and daily review according to cGMP guidelines.
- Assist with document control of all active and retired Master documents according to the QMS.
- BS in biology or related field.
- 1 – 2 years of experience in a laboratory setting, prefer experience in microbiology and/or bacteriophage biology.
- GMP experience preferred.
- 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.
- Outstanding organizational and communication skills.
- Ability to work independently and as part of a team
- Self-motivation, adaptability, and a positive attitude
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to [email protected]
Job ID: 2020-006