Associate Director, Drug Product Analytical Science and Technology
Bristol Myers Squibb
16 days ago
Remote friendly (Summit, NJ)
United States
Operations
Position Summary
Technical oversight of the analytical method lifecycle within Cell Therapy Analytical Science and Technology; lead scientists providing analytical SME support to Commercial Quality Control for investigations, method validation/transfers, regulatory submissions, and Health Authority interactions. Oversee operational workflows, metrics, and quality events (actions and investigations).
Duties/Responsibilities
- Lead and manage a team of analytical SMEs for commercial drug product release methods (cellular biology, molecular, flow cytometry).
- Provide technical oversight for method performance troubleshooting, evaluation of analytical methods/data from internal/external labs, including OOS/OOT/aberrant result investigations.
- Oversee method performance metrics and completion of quality events (actions/investigations) in electronic systems.
- Act as SME in functional areas as needed.
- Partner with analytical development and Commercial QC on method optimization/automation to improve productivity and reduce testing cost.
- Interface with analytical development on method qualification strategies.
- Hire, mentor, and develop ASAT personnel.
Qualifications (Required/Preferred)
- Bachelor’s in relevant scientific discipline (advanced degree preferred).
- 10+ years relevant experience (GMP/regulatory preferred) in cellular or gene therapy; 2+ years Analytical Science.
- 5+ years leadership.
- Analytical method lifecycle experience (transfer, validation, maintenance).
- Advanced QMS 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; travel required.
Compensation/Benefits (as stated)
- Salary ranges: Devens, MA $168,930–$204,702; Seattle, WA $173,660–$210,439; Summit West, NJ $157,880–$191,312.
- Health coverage; wellbeing support; 401(k); disability/life/insurance; Paid Time Off (flexible time off/paid vacation and holidays per location/role).
Application instructions
- If the role doesn’t perfectly match your resume, apply anyway.
Technical oversight of the analytical method lifecycle within Cell Therapy Analytical Science and Technology; lead scientists providing analytical SME support to Commercial Quality Control for investigations, method validation/transfers, regulatory submissions, and Health Authority interactions. Oversee operational workflows, metrics, and quality events (actions and investigations).
Duties/Responsibilities
- Lead and manage a team of analytical SMEs for commercial drug product release methods (cellular biology, molecular, flow cytometry).
- Provide technical oversight for method performance troubleshooting, evaluation of analytical methods/data from internal/external labs, including OOS/OOT/aberrant result investigations.
- Oversee method performance metrics and completion of quality events (actions/investigations) in electronic systems.
- Act as SME in functional areas as needed.
- Partner with analytical development and Commercial QC on method optimization/automation to improve productivity and reduce testing cost.
- Interface with analytical development on method qualification strategies.
- Hire, mentor, and develop ASAT personnel.
Qualifications (Required/Preferred)
- Bachelor’s in relevant scientific discipline (advanced degree preferred).
- 10+ years relevant experience (GMP/regulatory preferred) in cellular or gene therapy; 2+ years Analytical Science.
- 5+ years leadership.
- Analytical method lifecycle experience (transfer, validation, maintenance).
- Advanced QMS 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; travel required.
Compensation/Benefits (as stated)
- Salary ranges: Devens, MA $168,930–$204,702; Seattle, WA $173,660–$210,439; Summit West, NJ $157,880–$191,312.
- Health coverage; wellbeing support; 401(k); disability/life/insurance; Paid Time Off (flexible time off/paid vacation and holidays per location/role).
Application instructions
- If the role doesn’t perfectly match your resume, apply anyway.