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

MSD • Rahway, NJ

8d

About The Position

The Director will work in the Pharmaceutical Analysis and Digital Technologies department within the Development Sciences and Clinical Supplies organization, leading approximately 10–12 scientists who support externalized analytical deliverables for large-molecule programs at various development stages. The role leads realization of the organization’s externalization strategy, fosters scientific and operational excellence within the team and among external partners, and develops team talent. The position manages a broad portfolio of Biologics, Antibody Drug Conjugate, and/or Vaccine programs and requires expertise in large-molecule analytical method development and qualification, Quality Control, and strategic partner relationship management.

The Director works with internal stakeholders across Process, Quality Assurance, and Manufacturing to ensure external networks supplement internal capacity and capability, and to support transformation at strategic external partners. The role oversees multiple programs at the interface of clinical supply and commercialization, with a focus on broadening large-molecule CMC development capabilities and bringing pipeline candidates to patients.

The position requires a Ph.D. with at least 8 years of experience, a master’s degree with at least 10 years, or a bachelor’s degree with at least 15 years. Domestic and/or international travel may be up to 10%. The primary location is Rahway, New Jersey. The role is regular, and visa sponsorship is available.

Requirements

• Ph.D. degree and a minimum of 8 years of experience, or a master’s degree and a minimum of 10 years of experience, or a bachelor’s degree and a minimum of 15 years of experience.
• Subject-matter expertise in large-molecule analytical method development and qualification.
• Proficiency in Quality Control and ability to manage relationships with strategic partners.
• Strong knowledge of the Biologics CMC landscape, including GMP and relevant health authority guidelines.
• Experience with a variety of analytical methods, including microbiological, device, potency assay, biochemical, and/or biophysical characterization.
• People leadership and management capability.
• Adaptability and strong analytical thinking and scientific analysis skills.
• Skills in analytical chemistry, analytical method development, chromatography, laboratory research, drug development, pipeline development, commercialization, regulatory compliance, regulatory submissions, and BLA-related work.

Nice To Haves

• Outstanding communication, critical-thinking, and negotiation skills.
• Project management experience, including resource management, budget forecasting, and risk assessment and mitigation planning.
• Comfort working in a fast-paced and dynamic environment.
• Experience at the development/commercialization interface, with a track record of moving pipeline assets to commercial products.
• Demonstrated track record of delivering exceptional results across networks.
• Ability to critically review and interpret complex scientific and technical data to support data-driven decision-making.

Responsibilities

• Execute DSCS’s externalization strategy and optimize the operating model to deliver results aligned with enterprise goals.
• Oversee external-partner analytical deliverables, including quality control, for drug substance and drug product to support continuity of clinical supply.
• Oversee analytical method qualifications and transfers and resolution of analytical issues under GMP regulations.
• Build external analytical capabilities by working with internal subject-matter experts to upskill strategic partners.
• Oversee transfer of methods to commercial QC laboratories in support of registrational targets.
• Ensure external partners produce high-quality documentation consistent with a compliance mindset.
• Work with ACO leadership to optimize the current operating model and shape the future direction of the team.
• Lead and develop a team of approximately 10–12 scientists, leveraging individual strengths and development plans to drive results.
• Manage a broad portfolio of Biologics, Antibody Drug Conjugate, and/or Vaccine programs.
• Work with internal stakeholders across Process, Quality Assurance, and Manufacturing to ensure external networks supplement internal capacity and capability.
• Drive transformation at external strategic partners by leveraging the company’s ways of working.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director