Associate Director, Drug Product Analytical Science and Technology
Bristol Myers Squibb
13 hours ago
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
Position Summary:
Technical oversight of the analytical method lifecycle within Cell Therapy Analytical Science and Technology. Lead a team providing analytical subject matter expertise to Commercial Quality Control for investigations, method validation and transfers, regulatory submissions, Health Authority interactions, and operational workflows/metrics/quality events (actions and investigations).
Duties/Responsibilities:
- Lead and manage analytical Subject Matter Experts (SMEs) for commercial drug product release methods (cellular biology, molecular, flow cytometry).
- Provide technical oversight for method performance troubleshooting, evaluation of test methods/data from internal/external labs, including investigations of out-of-specification/out-of-trend/aberrant results.
- Oversee method performance metrics and completion of quality events (actions/investigations) in electronic systems.
- Serve as SME as needed.
- Partner with analytical development and Commercial QC to identify method optimization/automation to improve productivity and reduce testing cost.
- Interface with analytical development on method qualification strategies.
- Hire, mentor, and develop ASAT personnel.
Reporting Relationship:
Reports to Director of Drug Product Analytical Sciences and Technology (ASAT), Cell Therapy.
Qualifications:
- Bachelor’s degree required (relevant scientific discipline); advanced degree preferred.
- 10+ years relevant experience (preferably GMP/regulatory environment; cellular or gene therapy) and 2+ years Analytical Science.
- 5+ years leadership experience.
- Analytical method lifecycle experience (transfer/validation/maintenance).
- Advanced Quality Management knowledge (SOPs, Change Controls, Deviations, CAPAs, Risk Assessments, data integrity).
- Advanced regulatory understanding (FDA, EMA, ICH, USP, EP).
- Strong communication, cross-functional collaboration, mentoring/coaching, and ability to travel.
Compensation Overview:
US$157,880–$210,439 depending on location (Devons-MA, Seattle-WA, Summit West-NJ); additional incentive opportunities may be available.
Application Instructions:
Apply even if you don’t perfectly match the resume.
Technical oversight of the analytical method lifecycle within Cell Therapy Analytical Science and Technology. Lead a team providing analytical subject matter expertise to Commercial Quality Control for investigations, method validation and transfers, regulatory submissions, Health Authority interactions, and operational workflows/metrics/quality events (actions and investigations).
Duties/Responsibilities:
- Lead and manage analytical Subject Matter Experts (SMEs) for commercial drug product release methods (cellular biology, molecular, flow cytometry).
- Provide technical oversight for method performance troubleshooting, evaluation of test methods/data from internal/external labs, including investigations of out-of-specification/out-of-trend/aberrant results.
- Oversee method performance metrics and completion of quality events (actions/investigations) in electronic systems.
- Serve as SME as needed.
- Partner with analytical development and Commercial QC to identify method optimization/automation to improve productivity and reduce testing cost.
- Interface with analytical development on method qualification strategies.
- Hire, mentor, and develop ASAT personnel.
Reporting Relationship:
Reports to Director of Drug Product Analytical Sciences and Technology (ASAT), Cell Therapy.
Qualifications:
- Bachelor’s degree required (relevant scientific discipline); advanced degree preferred.
- 10+ years relevant experience (preferably GMP/regulatory environment; cellular or gene therapy) and 2+ years Analytical Science.
- 5+ years leadership experience.
- Analytical method lifecycle experience (transfer/validation/maintenance).
- Advanced Quality Management knowledge (SOPs, Change Controls, Deviations, CAPAs, Risk Assessments, data integrity).
- Advanced regulatory understanding (FDA, EMA, ICH, USP, EP).
- Strong communication, cross-functional collaboration, mentoring/coaching, and ability to travel.
Compensation Overview:
US$157,880–$210,439 depending on location (Devons-MA, Seattle-WA, Summit West-NJ); additional incentive opportunities may be available.
Application Instructions:
Apply even if you don’t perfectly match the resume.