Director, Vaccine Potency Development

Job Description

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.

Responsibilities include:
? Providing strategic, scientific, and operational management to the group responsible for developing fit for purpose assays and generate 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 over-sight 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.

Education Guidelines:
? Ph.D. in analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 8 years of relevant experience;
? OR M.S. with a minimum of 12 years of experience;
? OR Bachelors with a minimum of 15 years of experience in the Pharmaceutical Industry.

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

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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 click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another?s thinking and approach problems collectively.

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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 as ?remote?.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles? Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
Domestic/International

VISA Sponsorship:
Yes

Travel Requirements: 10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
04/21/2025
? A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R341336

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