Shift Available:
- SundayโWednesday, Onsite Night Shift, 6 p.m.โ4:30 a.m.
Responsibilities:
- Lead and oversee Label Operations for the S12 Cell Therapy manufacturing facility (Summit, NJ) in accordance with BMS policies/standards/procedures and Global cGMPs.
- Supervise label control activities for Cell Therapy Development and Operations (CTDO); develop/maintain a GMP-compliant clinical and commercial label issuance and control process.
- Oversee daily label operations, ensure compliance, and proactively address label control compliance issues.
- Act as site lead for clinical/commercial label management system implementation; support projects within timelines.
- Ensure timely issuance of in-process and final product labels; coordinate deliverables for launches and quality activities.
- Create employee development plans; ensure adequate staffing; coach/mentor on training, discipline, problem solving, and growth.
- Support electronic label issuance/control systems.
- Write/review/update SOPs; manage archival of batch records and GMP documentation.
- Perform gap assessments; develop/maintain quality metrics; collaborate to resolve quality system issues.
- Onboard new label control staff; maintain cGMP and global regulatory knowledge; perform additional investigations/projects as required.
Qualifications/Requirements:
- B.S. degree (or equivalent education/experience).
- 5+ years relevant work experience.
- 2+ years leadership experience.
Skills/Knowledge:
- Advanced GMP/Quality/compliance/risk management; strong authorship and report review; decision-making/problem solving; coaching/mentoring; independent mindset; strong communication; proficient with Microsoft Office.
Compensation (summary): $103,560โ$125,495 (Summit West โ NJ โ US).