Director, External Capabilities, Analytical Capabilities and Operations (ACO)

Merck & Co.; Rahway (NJ); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Merck & Co. in Rahway, NJ, is seeking a highly experienced leader to head the Pharmaceutical Analysis and Digital Technologies group within Development Sciences and Clinical Supplies.

You will manage a team of 10–12 scientists overseeing externalized analytical deliverables across Biologics, ADCs, and vaccines, ensuring regulatory compliance and seamless collaboration with internal Process, QA, and Manufacturing teams.

Formación

• Ph.D. with minimum 8 years experience or Master's with 10 years or Bachelor's with 15 years of experience.
• Pharmacology/CMC related expertise strongly preferred.
• Experience in overseeing large molecule analytical method development and external collaborations.

Responsabilidades

• Execute externalization strategy and optimize operating model to deliver results.
• Oversee analytical deliverables for drug substance/product at external partners under GMP.
• Develop external analytical capabilities with internal SMEs.
• Transfer methods to commercial QC labs to support registrational targets.
• Ensure high-quality documentation consistent with compliance standards.
• Collaborate with ACO leadership to shape team direction and pipeline assets.

Conocimientos

Adaptability

Analytical Chemistry

Analytical Method Development

Analytical Thinking

Biologics License Application (BLA)

Chemistry

Chromatographic Techniques

Commercialization

Drug Development

Laboratory Research

People Leadership

People Management

Pipeline Development

Regulatory Compliance

Regulatory Submissions

Scientific Analysis

Scientific Research

Team Leadership

Educación

Ph.D. in a related field

Master's degree

Bachelor's degree

Descripción del empleo

Job Description

The selected candidate will work in the Pharmaceutical Analysis and Digital Technologies department within the Development Sciences and Clinical Supplies organization and lead a group of exceptionally talented scientists supporting externalized analytical deliverables for large molecule programs at various stages of development. The scope of the role will include realization of the Development Sciences and Clinical Supplies externalization strategy, driving a culture of scientific and operational excellence within our team and at our external partners, and developing talent to achieve exceptional results. The selected candidate will manage a team of ~10-12 scientists and manage a broad portfolio of Biologics, Antibody Drug Conjugate, and/or Vaccine programs. The leader will be expected to demonstrate subject matter expertise across large molecule analytical method development and qualification, proficiency in Quality Control and ability to manage relationships with strategic partners. The leader will work with internal stakeholders across Process, Quality Assurance, and Manufacturing to ensure an external network exists to supplement internal capacity and capability and drive transformation at external strategic partners by leveraging our company's ways of working. The leader will be expected to work with direct reports and leverage their strengths to drive results while identifying opportunities to further develop each individual in alignment with their unique development plan. This role represents an excellent opportunity for a candidate seeking to lead a team of talented scientists, provide oversight of multiple programs, operate at the interface of clinical supply and commercialization, and broaden their experience in large molecule CMC development.

Primary Responsibilities

• Execution of DSCS's externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.
• Oversee analytical deliverables, inclusive of quality control, for all drug substance and drug product deliverables sited at external partners to ensure continuity of clinical supply (analytical method qualifications/transfers, and resolution of analytical issues under GMP regulations)
• Oversee external analytical capability build by working with internal SMEs to upskill strategic partners.
• Oversee transfer of methods to commercial QC laboratories in support of registrational targets.
• Ensure high-quality documentation from external partners consistent with a compliance mindset.
• Work with ACO leadership to optimize current operating model and shape the future direction of the team in order to bring promising pipeline candidates to patients.

Education Minimum Requirements

• A Ph.D. degree with a minimum of 8 years of experience
• OR a master's degree with a minimum of 10 years of experience
• OR a bachelor's degree with a minimum of 15 years of experience

Preferred Experience & Skills

• Outstanding communication, critical thinking, and negotiation skills.
• Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.
• Comfort with working in a fast-paced and dynamic environment.
• Strong knowledge of Biologics CMC landscape including knowledge of GMP and relevant HA guidelines.
• Experience with a wide variety of analytical methods, including microbiological, device, potency assay, biochemical and/or biophysical characterization.
• Experience working at the development/commercialization interface with a track record of moving pipeline assets to commercial products.
• Demonstrated track record of working across networks to deliver exceptional results.
• Demonstrated ability to critically review and interpret complex scientific and technical data to drive data-driven decision making
• Travel (Domestic and/or International) up to 10% of time

Required Skills

Adaptability, Analytical Chemistry, Analytical Method Development, Analytical Thinking, Biologics License Application (BLA), Chemistry, Chromatographic Techniques, Commercialization, Drug Development, Laboratory Research, People Leadership, People Management, Pipeline Development, Regulatory Compliance, Regulatory Submissions, Scientific Analysis, Scientific Research, Team Leadership

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US and Puerto Rico Residents Only

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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.

Additional location(s)

Please note the salary range above applies to the Primary Location of this position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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

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

11/15/2026

*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

R422690