Director, External Capabilities, Analytical Capabilities and Operations (ACO)
About The Position
The Director will lead a group of 10–12 scientists in the Pharmaceutical Analysis and Digital Technologies department within Development Sciences and Clinical Supplies. The team supports externalized analytical deliverables for large-molecule programs at various stages of development. The role is responsible for realizing the organization’s externalization strategy, fostering scientific and operational excellence within the team and among external partners, and developing talent. The leader will oversee a broad portfolio of biologics, antibody-drug conjugate, and/or vaccine programs, applying expertise in large-molecule analytical method development and qualification, quality control, and strategic partner relationships. The Director will collaborate with internal stakeholders across Process, Quality Assurance, and Manufacturing to maintain an external network that supplements internal capacity and capabilities. The role will also drive transformation at strategic external partners using the company’s ways of working, oversee work across the clinical supply and commercialization interface, and help bring pipeline candidates to patients.
Requirements
- Ph.D. degree and a minimum of 8 years of experience, or master’s degree and a minimum of 10 years of experience, or 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.
- Strong knowledge of the Biologics CMC landscape, including GMP and relevant health authority guidelines.
- Experience with analytical methods, including microbiological, device, potency assay, biochemical, and/or biophysical characterization.
- Outstanding communication, critical-thinking, and negotiation skills.
- Project management experience, including resource management, budget forecasting, and risk assessment and mitigation planning.
- Ability to work in a fast-paced and dynamic environment.
- Demonstrated ability to work across networks to deliver results.
- Demonstrated ability to critically review and interpret complex scientific and technical data to support data-driven decision-making.
- Travel domestically and/or internationally up to 10% of the time.
- Required skills include 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, and team leadership.
Nice To Haves
- Experience working at the development/commercialization interface, with a track record of moving pipeline assets to commercial products.
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.
- 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 team’s future direction.
- Lead and develop a team of 10–12 scientists, using direct reports’ strengths to drive results and supporting their individual development plans.
- Manage a broad portfolio of biologics, antibody-drug conjugate, and/or vaccine programs.
- Work with internal stakeholders across Process, Quality Assurance, and Manufacturing to maintain an external network that supplements internal capacity and capability.
- Manage relationships with strategic partners and drive transformation at those partners.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and families.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
