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

MSD•Upper Gwynedd Township, PA

1d•$173,200 - $272,600

About The Position

The Director will work in the Pharmaceutical Analysis and Digital Technologies department within the Development Sciences and Clinical Supplies organization, leading a group of approximately 10–12 scientists who support externalized analytical deliverables for large-molecule programs at various development stages. The role will realize the organization’s externalization strategy, promote scientific and operational excellence within the team and among external partners, develop talent, and manage a broad portfolio of biologics, antibody-drug conjugate, and/or vaccine programs. The leader will provide subject-matter expertise in large-molecule analytical method development and qualification, Quality Control, and strategic partner relationship management. Working with internal stakeholders across Process, Quality Assurance, and Manufacturing, the Director will ensure that an external network supplements internal capacity and capability and will drive transformation at strategic external partners. The role also involves developing direct reports according to their individual development plans and providing oversight across programs at the interface of clinical supply and commercialization. The position is based primarily in Rahway, New Jersey, with travel of up to 10% domestically and/or internationally. The employee may be eligible for an annual bonus and long-term incentive, if applicable. Relocation and visa sponsorship are available.

Requirements

Ph.D. and at least 8 years of experience, or master’s degree and at least 10 years of experience, or bachelor’s degree and at least 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.
People leadership and people management skills.
Skills in adaptability, analytical chemistry, analytical method development and thinking, chemistry, chromatographic techniques, commercialization, drug development, laboratory research, pipeline development, regulatory compliance and submissions, scientific analysis and research, and team leadership.

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 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 support data-driven decision-making.

Responsibilities

Execute the Development Sciences and Clinical Supplies 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, including 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 Quality Control 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 their strengths and supporting individual development plans.
Manage a broad portfolio of biologics, antibody-drug conjugate, and/or vaccine programs and strategic partner relationships.
Work with internal stakeholders across Process, Quality Assurance, and Manufacturing to ensure the external network supplements internal capacity and capability and to drive transformation at strategic partners.