Director, External Capabilities, Analytical Capabilities and Operations; ACO

Position: Director, External Capabilities, Analytical Capabilities and Operations (ACO)
Location: West Point

Job Description

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…