Distinguished Scientist, Microbiology

** Job Description*
* 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.

** Education Minimum Requirement:*
* + 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.

** Required

Experience and Skills:

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* + 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

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* Required Skills:

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* 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,…