Executive Director, Microbiology

MSD•Rahway, NJ

1d•$231,900 - $365,000•Hybrid

About The Position

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.

Requirements

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.
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.
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

Responsibilities

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).
Oversight of GMP release and stability activities supporting the development pipeline.
Oversight of facility environmental monitoring.
Oversight of analytical method transfers from embedded microbiology development teams.
Oversight of transfer support to commercial sites.
Support for regulatory filings including INDs, IMPDs, NDAs, and BLAs.
Responsibility for molecular and viral screening.
Responsibility for cell bank testing oversight.
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; and Quality, Commercialization, and Manufacturing partners.
Partnering across the 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.
Engaging 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.
Interfacing closely with partner groups to ensure aligned methodologies for all critical quality attributes (CQAs) tested on process intermediates.
Directly responsible for a team of approximately sixty internal and external scientists.
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.
Ensuring GMP execution with the highest scientific standards.
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.
Facilitating and participating in on-site audits and inspections.
Recruiting, appraisal, and development of personnel under their supervision.
Selecting, training, and working effectively with colleagues to implement development plans for personnel under their direction within the framework of Company policy.
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.
Advancing a culture of scientific excellence, a strong GMP and compliance mindset, and effective alliance with partners and stakeholders across development.