Distinguished Scientist, Microbiology

Merck•Rahway, NJ

4d•$210,400 - $331,100•Hybrid

About The Position

The Distinguished Scientist, Microbiology is accountable for partnering with the executive director of microbiology to define strategic and technical capability build to support small molecule, biologics and vaccine candidates in the clinical development space across the Research and Development (R&D) Microbiology Network (site-based teams in Rahway, NJ; West Point, PA; Schachen, Switzerland). Although the role of Distinguished Scientists is an individual contributor role, the incumbent will be expected to provide enterprise level decision making and technical and scientific leadership across the Microbiology Network and engage with industry forums and regulatory partners to advance forward-looking microbiology and control strategies. The Distinguished Scientist will provide strategic/technical oversight of 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). 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 scope also includes 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; 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 role will play a key leadership position in capability build across the microbiology network, including defining and advancing a Next Generation Sequencing (NGS) strategy and driving implementation of rapid microbiological methods (RMM). This includes establishing technical standards, deployment roadmaps, and integration of these technologies into routine testing and regulatory control strategies. 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; and implementing innovative analytical approaches while 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; overseeing change management documentation, investigations, and corrective action plans; and participating in audits and inspections. The successful candidate will be an scientific experienced leader and must be able to partner effectively in a fast-paced, multidisciplinary team environment, with strong expertise in microbiological, analytical techniques and project leadership.

Requirements

Ph.D. in microbiology or a related field with 10+ years of relevant experience in the pharmaceutical industry; OR M.S. with 12+ years of relevant experience; OR B.S. with 16+ 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 initiatives and influence without direct authority
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
Cell-Based Assays
Clinical Development
Dosage Forms
Exercises Judgment
GMP Compliance
Intellectual Curiosity
Mentorship
Microbiological Analysis
Microbiological Cultures
Microbiology
Molecular Microbiology
Molecular Structure
Professional Networking
Project Leadership
Regulations
Regulatory Compliance
Scientific Leadership
Technical Reporting

Nice To Haves

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Responsibilities

Provide enterprise level decision making and technical and scientific leadership across the Microbiology Network.
Engage with industry forums and regulatory partners to advance forward-looking microbiology and control strategies.
Provide strategic/technical oversight of raw material testing and in-process control (IPC) analysis.
Interface closely with partner groups to ensure aligned methodologies for all critical quality attributes (CQAs).
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.
Transfer support to commercial sites.
Support for regulatory filings including INDs, IMPDs, NDAs, and BLAs.
Oversight of molecular and viral screening.
Oversight of cell bank testing.
Evaluation and implementation of new analytical technologies, including the continued development and execution of advanced microbiology methodologies.
Define and advance a Next Generation Sequencing (NGS) strategy.
Drive implementation of rapid microbiological methods (RMM).
Establish technical standards, deployment roadmaps, and integration of these technologies into routine testing and regulatory control strategies.
Deliver phase-appropriate qualification/validation and verification of compendial microbiological and IPC assays.
Ensure on-time execution of release, stability, and environmental monitoring.
Implement innovative analytical approaches while ensuring GMP execution with the highest scientific standards.
Manage area status and GMP readiness, including oversight of equipment readiness and documentation systems.
Author, review, and approve GMP documentation.
Review and approve site and global SOPs.
Oversee change management documentation, investigations, and corrective action plans.
Participate in audits and inspections.