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.