Associate Director, Drug Product Analytical Science and Technology

Bristol Myers Squibb • Seattle, WA

4d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in relevant scientific discipline or equivalent is required.
• 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 interaction skills.
• Ability to travel to other BMS sites or Partner sites is required.

Nice To Haves

• Advanced degree preferred.

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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

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