Merck · 6 hours ago
Director, Vaccines Potency in Analytical Research & Development
Lansdale, PA
Full-time
Hybrid
Director/Executive
$173K/yr - $273K/yr
8+ years expMerck is seeking an exceptional leader for their team in West Point, PA, focusing on analytical solutions in vaccine development. The Director will provide strategic and technical leadership, overseeing assay design and development while managing a team of scientists to ensure product safety and quality.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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 bachelor's with a minimum of 15 years of experience in the Pharmaceutical Industry
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
Academic Quality Improvement Program (AQIP)
Accountability
Adaptability
Analytical Chemistry
Analytical Method Development
Assay
Biologics License Application (BLA)
Cell-Based Assays
Cell Physiology
Chromatographic Techniques
Communication
Data Quality Control
Decision Making
Dosage Forms
GMP Compliance
Molecular Biology
People Leadership
Pharmaceutical Management
Process Analytical Technology (PAT)
Professional Networking
Project Portfolio Management (PPM)
Regulatory Compliance
Regulatory Submissions
Results-Oriented
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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