Director, Vaccines Potency in Analytical Research & Development

Merck•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Our team in West Point, PA is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The Director of Vaccines Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion of the Vaccines development portfolio from discovery to launch. The Director will oversee the design and development of robust and reliable vaccine potency and functional characterization assays to inform process development and release and characterize drug substance and drug product. The Director reports to the Executive Director, Cell Based Sciences and will be responsible for a team of approximately 10-15 senior and associate level scientists. The position is accountable for developing analytical methods, assay transfer to GxP laboratories, and supporting regulatory filings including INDs/IMPDs and BLAs. The successful candidate will be responsible for strategic partnering with CMC development, Regulatory, Quality, and our partners in commercialization and manufacturing. The role will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture of innovation and inclusion.

Requirements

A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.
Expertise in applying expertise to solve complex scientific and operational challenges related to designing and developing GxP potency assays across all stages of vaccine development, which may include plaque, TCID50, infectivity assays, immunoassay, and/or reporter gene assays.
Strong knowledge and statistical skills for design of analytical comparability studies, and interpretation of potency data in context of broader process and product development.
Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with Health Authorities.
Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
Proven ability to direct development of new, innovative approaches including your past work with new assay or robotic technology evaluation and shaping scientific strategy both at the platform and program level.
Ability to effectively manage a portfolio of projects, multi-task in a highly dynamic environment, and influence cross-functional teams in a professional and positive manner.
Excellent verbal and written communications skills and an ability to excel in a team-based environment.
Strength in delivering results on firm deadlines in support of compound discovery, development and commercial filing

Responsibilities

Providing strategic, scientific, and operational management to the group responsible for developing fit for purpose assays, generating analytical data to drive decisions across process development, drug substance and drug product release, extended characterization, and clinical manufacturing.
Designing an integrated, phase-appropriate potency strategy. This includes building strong interfaces with project teams, GMP, and late-stage commercialization partners.
Actively mentor staff to encourage and facilitate their personal and scientific development.
Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset, and collaboration with partners and stakeholders in development.
Setting future strategies and sponsoring new technologies.
Responsible for scientific oversight of work outsourced to Clinical Research Organizations (CROs) in collaboration with others to ensure data quality and accuracy is aligned with our company's expectations.