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.

Major responsibilities:

  • 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.

Job requirements:

  • 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