Associate Director, Drug Product Analytical Science and Technology

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Position Summary:

This leadership role will be responsible for the technical oversight of the analytical method lifecycle within the Cell Therapy Analytical Science and Technology organization.  This role will lead a team of scientists providing analytical subject matter expertise to the commercial Quality Control organization during investigations, commercial drug product method validation and transfers, regulatory submissions and Health Authority interactions.  In addition, the Associate Director role will oversee operational workflows, metrics, and quality events including actions and investigations.

Duties/Responsibilities:

• Lead and manage a team of analytical Subject Matter Experts (SME) responsible for the commercial drug product release methods utilized in the cellular biology, molecular and flow cytometry areas.

• Provide technical oversight and guidance to team as needed in support of method performance troubleshooting, evaluation of analytical test methods and data generated by internal and external laboratories, including investigations related to out of specification, out of trend, and aberrant results.

• Oversee method performance metrics and the team’s completion of quality events including actions and investigations within electronic systems.

• Act as a Subject Matter Expert (SME) in functional areas as needed.

• Partner with analytical development and the commercial QC organization to identify method optimization and automation opportunities to enhance productivity and reduce the cost of product testing.

• Interface with analytical development functions on method qualification strategies.

• Hire, mentor, and develop exceptional ASAT personnel.

Reporting Relationship:

This position will report to the Director of Drug Product Analytical Sciences and Technology (ASAT), Cell Therapy.

Qualifications:

• Bachelor’s degree in relevant scientific discipline or equivalent is required.  Advanced degree preferred.

• 10+ years of relevant experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy and 2+ years’ experience in Analytical Science.

• 5+ years of leadership experience

• Experience in analytical method lifecycle, including method transfer, validation, and maintenance.

• Advanced knowledge and implementation of Quality Management inclusive of SOPs, Change Controls, Deviations, CAPAs, Risk Assessments and data integrity principles.

• Advanced understanding of regulatory requirements and guidelines as related to the manufacture of cell therapy products (FDA, EMA, ICH, USP, and EP guidelines)

• Self-directed with a high degree of professional integrity, highly organized and detail oriented. Ability to work independently and to collaborate cross functionally to drive operational and quality excellence.

• Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.

• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences including ability to interpret and author general, technical, and complex business documents.

• Advance ability to communicate effectively with peers, department management, cross-functional peers.

• Advanced mentoring and coaching, influencing, negotiating, and personal in