Director, QC & Microbiology

The Director, QC & Microbiology provides strategic and operational leadership for the site's Quality Control Chemistry and Microbiology functions, ensuring scientific excellence, regulatory compliance, laboratory capacity, and organizational capability support current operations and future growth. This leader oversees laboratory performance, analytical and microbiological testing, environmental monitoring, investigations, laboratory systems, and continuous improvement while serving as a key partner to site leadership and cross-functional teams.

Responsibilities

Provide strategic and operational leadership for the site's Quality Control Chemistry and Microbiology functions; Oversee laboratory performance, analytical and microbiological testing, environmental monitoring, investigations, laboratory systems, and continuous improvement; Ensure staffing, laboratory capacity, instrumentation, and technical capabilities support current operations and future growth; Represent QC and Microbiology during regulatory inspections, client audits, governance meetings, and leadership reviews; Oversee raw material, in-process, release, stability, environmental, utility, and microbiological testing; Ensure analytical and microbiological methods are appropriately validated, transferred, maintained, and scientifically sound; Maintain continuous inspection readiness and compliance with GMP requirements; Build and lead an accountable, engaged, and technically capable QC and Microbiology organization; Develop managers, supervisors, technical leaders, and succession plans for critical roles

Requirements

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a life sciences field required; Typically 12 or more years of progressive pharmaceutical, biotechnology, or CDMO laboratory experience; Experience overseeing large departments including direct and indirect reports; Significant leadership experience in QC Chemistry and Microbiology within a GMP-regulated environment; Experience with analytical testing, microbiological control, environmental monitoring, method transfer, stability, investigations, and data integrity; Demonstrated experience as subject matter expert in regulatory inspections, client audits, and compliance remediation; Experience with laboratory electronic systems, including LIMS, CDS, and SDMS; Strong strategic, technical, people-leadership, communication, and decision-making skills

Nice to have

MS or PhD degree preferred; Experience in sterile, biologic, parenteral, or multi-client CDMO operations highly preferred

Benefits

Paid time off; health insurance coverage (including dental and vision); flexible spending account; 401(k); eligibility for annual performance bonus