Clinical Assay Laboratory Manager
Exciting opportunity for experienced analytical leader to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections.
The Clinical Assay Laboratory Manager will manage the day-to-day operations of the Clinical Lab Team, including direction of staff. The Clinical Assay Laboratory Manager will work collaboratively across internal functions including Clinical Operations, Development, Quality, Regulatory Affairs, and Supply Chain to ensure clinical testing and data reporting deliverables are met while maintaining data integrity. Assist in the design of and startup of the clinical laboratory, including equipment installation and qualification and hiring of staff. Further develop, implement, maintain, and improve phase appropriate processes and procedures supporting Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practices (GCLP). Conduct clinical testing (viral plaque assays, clinical specimen processing, neutralizing antibody testing, phage and bacterial quantification, genomic extractions, PCR). Leads the conduct and reporting of clinical testing including phage susceptibility, antibiotic susceptibility, antibiotic-phage interaction, and phage-phage interaction in planktonic and biofilm-associated bacterial species. This testing will directly support APT's sponsored clinical trials (Phase 1-3) and APT's expanded access programs. Assist in assay transfer, qualification, and validation activities. Provides leadership, direction, and mentorship across all levels of the organization to assure strategies are known and implemented. Acts as point of contact (POC) on Clinical Laboratory matters, internally and externally.
- Responsible for day-to-day operations of the Clinical Assay Lab team.
- Lead and direct clinical sample testing. Includes provision of data reports and regulatory filing content.
- Execute lab testing, if needed.
- Works as POC to provide technical expertise on deviations and investigations.
- Ensures work is conducted following cGMP requirements and APT procedures, including ensuring data integrity.
- Quickly identify and resolve gaps and provide expertise during complex troubleshooting.
- Write technical documents such as protocols, reports, change controls, investigations, and SOPs. Includes reviewing and approving these document types.
- Hire, develop, and retain 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 microbiology 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. Advanced degree preferred
- 5+ years of experience in the pharmaceutical and biotechnology industries
- 3+ years supervisory experience in industry
- ASCP certification preferred
- 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