Exciting opportunity for experienced analytical leader to join Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections.
The Quality Control (QC) Manager will manage the day-to-day operations of the QC Team, including direction of staff. The QC Manager will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure QC deliverables are met. Assist in the design of phase-appropriate QC systems including implementation and continuous improvement to ensure patient safety and data integrity. Assist in assay qualification and validation activities. Provide leadership, direction, and mentorship across all levels of the organization to assure QC strategies are known and implemented. Act as a back-up point of contact (POC) on QC matters, internally and externally.
- Responsible for day-to-day operations of the QC team.
- Lead and direct testing (GMP and non-GMP) of critical reagents, in-process, release, and stability testing. Includes provision of certificate of analysis (CoA) content and regulatory filing content.
- Execute lab testing, if needed.
- Work as QC POC to provide technical expertise on deviations, OOS/OOT investigations. Act as QC Lead on QC related deviations and investigations.
- Ensure QC work is conducted following cGMP requirements and APT procedures.
- Quickly identify and resolve gaps and provide expertise during complex troubleshooting.
- Write technical documents such as reports, change controls, investigations, and SOPs. Includes reviewing and approving these document types.
- Hire, develop, and retain QC personnel (including temporary, contract, and/or consultant staff) to maintain a high-performing credible team.
- Facilitate maintenance of the lab areas including general housekeeping, inventory, and equipment.
- Communicate effectively and cross-functionally.
- Participate in audits as needed (internal, regulatory, and/or partner).
- Skilled in assay qualification and validation.
- Ability to solve complex technical issues and drive to closure.
- Skill in building and maintaining cross functional relationships across areas.
- Ability to manage multiple priorities with a sense of urgency to meet timelines.
- Adaptable to change.
- Excellent communication skills; verbal and written; with various levels of internal and external organizations.
- Bachelor of Science degree / equivalent in life sciences or related field
- 5+ years of experience in the pharmaceutical and biotechnology industries
- 3+ years supervisory experience in industry
- Strong knowledge of FDA and ex-US regulations in development through commercial, including assay qualification and validation
- Experience in microbiology and virology preferred
- Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint)
- Experience with government contracting desired.
Compensation: Salary is industry-standard and is commensurate with experience.
To apply: Please email cover letter and resume to [email protected]
Job ID: 21.025