Associate Vice President, Large Molecule Analytical R&D

Job Description

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.

Key Responsibilities:

Strategic Leadership & Innovation

• 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.

Operational Excellence & Compliance

• 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.

Team Building & Talent Development

• 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.

Cross-Functional Collaboration & Stakeholder Management

• 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.

Project & Resource Management

• 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.

Education:

• 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.

Required Experience & Skills:

• 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.

Preferred Experience and Skills:

• 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.

Location & Travel:

This role will be based on Rahway, NJ and will require travel across global sites including but not limited to New Jersey, Pennsylvania, Delaware, Switzerland, Ireland, and other locations.

Required Skills:
Accountability, Analytical Method Development, Bioanalytical Analysis, Clinical Data Interpretation, Communication, Customer Experience Management, Dosage Forms, Innovation, Leadership Initiatives, Mentoring Staff, Molecular Structure, Negotiation, Organizational Change Management, People Leadership, Stakeholder Management, Technical Reporting, Vision Casting

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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".

The salary range for this role is
$282,200.00 - $444,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
02/28/2026
*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: R387339