Senior Manager, Downstream Manufacturing
Bristol Myers Squibb
15 days ago
On-site
Devens, MA
Operations
Major Duties and Responsibilities:
- Lead and drive execution of commercial downstream manufacturing for therapeutic proteins in accordance with cGMP and electronic work instructions/production records.
- Manage one or more operational groups to meet goals/metrics; prioritize resources/activities and drive manufacturing schedule adherence/cycle time.
- Identify deficiencies, execute action plans, support investigations/troubleshooting, analyze process/equipment data, and implement process improvements.
- Ensure compliance with Good Manufacturing Practices and safe work practices; coordinate daily work and cross-functional variance communication in real time.
- Provide leadership for staffing performance, coaching/mentoring, performance reviews, CAPA/eCC actions, tier meetings documentation (MBRs/BOMs/SOPs), and direct audit support.
- Lead or support strategic initiatives and participate in maintenance/frozen schedule/IEF meetings; provide on-call/weekend/holiday support.
Knowledge and Skills (Qualifications):
- B.S. (science, engineering, biochemistry) or equivalent preferred/highly desired.
- 8+ years direct biologic manufacturing experience; 3+ years supervisory experience.
- Mastery of SOPs and cGMPs in a regulatory environment; strong biopharmaceutical manufacturing process knowledge.
- Cell culture operations experience highly desirable.
- Engineering principles/manufacturing automation aptitude; cross-functional supervisory experience.
- Strong technical communication and technical writing.
Compensation/Benefits:
- Devens, MA: $131,750–$159,650 (plus possible incentive cash/stock based on eligibility).
- Health coverage; wellbeing and EAP; 401(k), disability, life insurance, and other listed financial protection; paid time off (details by location/eligibility).
Application Instructions:
- If the role doesn’t perfectly match your resume, apply anyway.
- Lead and drive execution of commercial downstream manufacturing for therapeutic proteins in accordance with cGMP and electronic work instructions/production records.
- Manage one or more operational groups to meet goals/metrics; prioritize resources/activities and drive manufacturing schedule adherence/cycle time.
- Identify deficiencies, execute action plans, support investigations/troubleshooting, analyze process/equipment data, and implement process improvements.
- Ensure compliance with Good Manufacturing Practices and safe work practices; coordinate daily work and cross-functional variance communication in real time.
- Provide leadership for staffing performance, coaching/mentoring, performance reviews, CAPA/eCC actions, tier meetings documentation (MBRs/BOMs/SOPs), and direct audit support.
- Lead or support strategic initiatives and participate in maintenance/frozen schedule/IEF meetings; provide on-call/weekend/holiday support.
Knowledge and Skills (Qualifications):
- B.S. (science, engineering, biochemistry) or equivalent preferred/highly desired.
- 8+ years direct biologic manufacturing experience; 3+ years supervisory experience.
- Mastery of SOPs and cGMPs in a regulatory environment; strong biopharmaceutical manufacturing process knowledge.
- Cell culture operations experience highly desirable.
- Engineering principles/manufacturing automation aptitude; cross-functional supervisory experience.
- Strong technical communication and technical writing.
Compensation/Benefits:
- Devens, MA: $131,750–$159,650 (plus possible incentive cash/stock based on eligibility).
- Health coverage; wellbeing and EAP; 401(k), disability, life insurance, and other listed financial protection; paid time off (details by location/eligibility).
Application Instructions:
- If the role doesn’t perfectly match your resume, apply anyway.