Associate Vice President, Large Molecule Analytical R&D

Merck•Rahway, NJ

3h•Hybrid

About The Position

The Associate Vice President (AVP), Large Molecule Analytical R&D, is a senior leadership role responsible for providing visionary scientific and strategic leadership in the development, validation, implementation, and commercialization of analytical methods supporting large molecule drug substances and drug products, including biologics, vaccines, cell therapies, and antibody-drug conjugates. This role drives innovation in analytical sciences, ensures regulatory compliance, and leads cross-functional teams to deliver high-quality analytical data critical for advancing the clinical and commercial pipeline. Reporting to the Senior Vice President of Development Sciences & Clinical Supply, the AVP will collaborate extensively across Research, Development, Manufacturing, Quality, and Regulatory functions, as well as external partners, to position the organization as a leader in large molecule analytical innovation.

Requirements

Minimum 15 years of progressive leadership experience in large molecule analytical development within pharmaceutical or biotech industries.
Proven track record in developing and commercializing analytical methods for biologics, vaccines, cell therapies, or related modalities.
Demonstrated success in leading large, multidisciplinary teams across multiple sites.
Strong expertise in regulatory submissions and interactions, including pre-licensure consultations and inspections.
Experience driving innovation and implementing new technologies in GMP environments.
Excellent interpersonal, communication, and collaboration skills with ability to influence senior leaders and external stakeholders.
Commitment to building inclusive teams and fostering a culture of psychological safety and continuous learning.
Ph.D. in Analytical Chemistry, Biochemistry, Immunology, Pharmaceutical Sciences, or related discipline is highly preferred.
Alternatively, a Master’s degree with extensive relevant experience (15+ years) is acceptable.

Nice To Haves

Recognized national/international scientific leader with publications, conference leadership, or professional association roles.
Experience with automation, Process Analytical Technology (PAT), data sciences, and machine learning applications in analytical development.
Experience managing cross-modality analytical functions (biologics, vaccines, cell therapy).
Experience in capital project sponsorship and laboratory modernization.

Responsibilities

Provide strategic scientific leadership and vision for large molecule analytical sciences across modalities (biologics, vaccines, cell therapies).
Originate, develop, and implement novel analytical technologies and approaches, including cell-based potency assays, automation, and data science/machine learning integration.
Lead the development and execution of analytical strategies that support pipeline advancement from preclinical through commercialization.
Influence senior leadership and external stakeholders by communicating scientific advances and representing the company at scientific forums, regulatory meetings, and industry consortia.
Oversee the development, validation, and technology transfer of analytical methods ensuring compliance with cGMP, GLP, and regulatory standards.
Ensure delivery of high-quality CMC analytical data and documentation to support IND, BLA, NDA, and other regulatory filings.
Maintain laboratory readiness for internal audits and regulatory inspections.
Drive continuous improvement initiatives to enhance analytical capabilities, reduce cost of goods, improve speed to patient, and increase manufacturing flexibility.
Build, lead, and mentor a high-performing and inclusive analytical team of scientists, managers, and technical experts across multiple global sites.
Foster a culture of innovation, psychological safety, and scientific excellence.
Develop succession plans and talent pipelines aligned with organizational goals.
Promote cross-functional collaboration and knowledge sharing.
Partner with Drug Substance Process Innovation, Pharmaceutical Sciences, Clinical Supply, Quality Assurance, and Regulatory Affairs to align analytical strategies with overall product development and manufacturing goals.
Lead interactions with regulatory agencies (e.g., FDA Emerging Technologies Team, ICH) to facilitate acceptance of new analytical technologies.
Manage external collaborations with academic, industry, and government partners to advance analytical science and technology.
Oversee leaders and actively manage multiple analytical projects ensuring timely delivery, quality, and alignment with business priorities.
Allocate resources effectively and manage budgets for large molecule analytical development and capital projects.
Sponsor modernization initiatives for large molecule analytical laboratories and facilities.