Executive Director, Microbiology

**Job Description**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. The team is also responsible for molecular and viral screening, cell bank testing oversight, and the evaluation and implementation of new analytical technologies, including the continued development and execution of advanced microbiology methodologies. Strategic partnering among Analytical, Process, and Formulation Research & Development teams; CMC and Regulatory functions (particularly around control strategy and regulatory filings); and Quality, Commercialization, and Manufacturing partners is essential to enable robust product and process development, ensure regulatory compliance, and support successful commercialization and lifecycle management. The incumbent will also play a key role in partnering across our Microbiology Network, collaborating 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. In addition, the incumbent will engage with industry forums and regulatory partners to shape and advance forward-looking microbiology and control strategies. The Executive Director will have oversight of all raw material testing and in-process control (IPC) analysis and will interface closely with partner groups to ensure aligned methodologies for all critical quality attributes (CQAs) tested on process intermediates. The Executive Director will be directly responsible for a team of approximately sixty internal and external scientists. The position is accountable for delivering phase-appropriate qualification/validation and verification of compendial microbiological and IPC assays; ensuring on-time execution of release, stability, and environmental monitoring; partnering with interfacing teams to transfer and implement forward-looking analytical technologies and innovative approaches; and ensuring GMP execution with the highest scientific standards. The incumbent will be responsible 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 (including oversight of the departmental SOP system); overseeing change management documentation, investigations, and corrective action plans; overseeing training plans and documentation; and facilitating and participating in on-site audits and inspections. The successful candidate will be an experienced leader and must be able to partner effectively in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including a strong background and experience in microbiological and analytical techniques, project and team management, and publication of research results. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under their supervision. The Executive Director selects, trains, and works effectively with colleagues to implement development plans for personnel under their direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary (including merit and promotion planning). Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, a strong GMP and compliance mindset, and effective alliance with partners and stakeholders across development. **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 Experience and Skills:*** Excellent verbal and written communication skills in English* Demonstrated creativity and strong interpersonal and collaborative skills.* Demonstrated 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.**Required Skills:**Analytical Chemistry, Analytical Chemistry, Analytical Method Development, Analytical Method Transfer, Biochemistry, Biologics, Chemical Engineering, Clinical Development, Clinical Microbiology, Cross-Functional Leadership, Documentations, Documentation Systems, End to End Process, Environmental Monitoring, Environmental Monitoring Systems, Ethical Compliance, GMP Compliance, GMP Guidelines, Innovation, Interpersonal Relationships, Microbiology, Molecular Microbiology, Molecular Structure, Pharmaceutical Management, Problem Solving {+ 7 more}**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**US and Puerto Rico Residents Only:**Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.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:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated #J-18808-Ljbffr MSD Malaysia