Executive Director, Microbiology

Executive Director, Microbiology The Executive Director, Microbiology is accountable for providing strategic and technical leadership supporting small molecule, biologics and vaccine candidates in the clinical development space across the Microbiology Network (site-based teams in Rahway, NJ; West Point, PA; Schachen, Switzerland). This includes oversight of GMP release and stability activities supporting the development pipeline, facility environmental monitoring, analytical method transfers from embedded microbiology development teams, transfer support to commercial sites, and support for regulatory filings including INDs, IMPDs, NDAs, and BLAs. Responsibilities Molecular and viral screening, cell bank testing oversight, and the evaluation and implementation of new analytical technologies, including continued development and execution of advanced microbiology methodologies. Strategic partnering among Analytical, Process, and Formulation Research & Development teams; CMC and Regulatory functions; and Quality, Commercialization, and Manufacturing partners to enable robust product and process development, ensure regulatory compliance, and support successful commercialization and lifecycle management. Collaboration with research site-based microbiology teams, analytical microbiology groups across the network, and commercial sites to ensure clear line-of-sight to microbiology method development, method transfers, and commercial testing. Engagement with industry forums and regulatory partners to shape and advance forward‑looking microbiology and control strategies. Oversight of all raw material testing and in-process control (IPC) analysis and interface closely with partner groups to ensure aligned methodologies for all critical quality attributes (CQAs) tested on process intermediates. Responsibility for managing area status and GMP readiness, including oversight of equipment readiness and documentation systems; authoring, reviewing, and approving GMP documentation; reviewing and approving site and global SOPs; overseeing change management documentation, investigations, and corrective action plans; overseeing training plans and documentation; and facilitating and participating in on‑site audits and inspections. Leadership of a team of approximately sixty internal and external scientists; recruitment, appraisal, and development of personnel; proactive resourcing planning, risk assessment strategies, and budget management. Qualifications and Experience Education Minimum Requirement: Ph.D. in microbiology or a related field with 8+ years of relevant experience in the pharmaceutical industry ; or M.S. with 10+ years of relevant experience ; or B.S. with 14+ years of relevant experience in the pharmaceutical industry. Required Skills: Excellent verbal and written communication skills in English, demonstrated creativity and strong interpersonal and collaborative skills, ability to lead cross-functional groups with proven talent‑development skillsets, ability to work effectively in a team environment with extensive cross-functional interactions, proven strength in delivering results against firm deadlines in support of the pipeline from development through commercialization, and proficiency in Analytical Chemistry, Analytical Method Development, Analytical Method Transfer, Biochemistry, Biologics, Chemical Engineering, Clinical Development, Clinical Microbiology, Cross-Functional Leadership, Documentation Systems, Environmental Monitoring, GMP Compliance, Innovation, Interpersonal Relationships, Microbiology, Molecular Microbiology, Pharmaceutical Management, and Problem Solving. Preferred Skills Experience with state-of-the-art analytical techniques to solve problems, including a strong background in microbiological and analytical techniques. Experience in project and team management, and publication of research results. Strong GMP and compliance mindset. Effective alliance with partners and stakeholders across development. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. Benefits & Compensation Salary range for this role is $231,900.00 – $365,000.00. The successful candidate will be eligible for an annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Further details are available at #J-18808-Ljbffr