Position Description: Microbiologist I/II – Quality Control
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 work alongside the upstream production team to perform QC testing of the therapeutic product per regulatory guidelines and/or SOPs including but not limited to: endotoxin quantification, HCP analysis, potency, visual inspection, and stability.
- Grow bacterial batch culture and amplify bacteriophages in batch cultures including working with single use disposable bioreactor systems.
- Perform in-process testing of material prior to releasing to downstream manufacturing team(s).
- Propagate, maintain, and catalogue bacterial cell and bacteriophage lines used for manufacturing of the therapeutic drug product.
- 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.
- May help in the ongoing development of scale up batch culture processes.
- 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: 2020-009