Supervisor, Manufacturing Assembly
$79,000–$120,700 year
On-site · Raritan, New Jersey, United States
Job Summary
Supervise lentiviral vector end-to-end manufacturing in a sterile cGMP environment for commercial BCMA CAR T product. Lead daily start-of-shift and wrap-up production meetings, assign tasks, ensure compliance with SOPs and batch records, collaborate across Manufacturing, Facilities, Engineering, and Quality, drive continuous improvements, support manufacturing investigations, and manage change controls. Requires strong leadership, cross-functional collaboration, ability to manage multiple priorities, shift work including evenings/weekends, and a Bachelor’s degree or equivalent with 2–4 years of cGMP biotech/biopharma operations experience. Knowledge of cGMP regulations, GMP, Lean/Operational Excellence, and proficiency with MES, SAP, and related systems highly desirable. Must be able to lift 25 lbs and stand for extended periods; travel up to 10%.
Required Qualifications
- Bachelor’s degree in Science, Engineering or related field or equivalent experience required
- A minimum of two to four (2-4) years of operations experience within a cGMP environment in biotech/biopharma industry is preferred
- Prior experience in an aseptic manufacturing environment and leadership positions
- Prior experience in manufacturing, quality, or engineering is required
- Experience with Operational Excellence and/or Lean Manufacturing is an asset
- Excellent communication and organizational behaviors skills are required
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required
- Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required
- Experience working in cGMP systems including MES lite, eLIMs, Siemens, and SAP is preferred
- Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required
- This position may require up to 10% of domestic travel
Desired Qualifications
- Bachelor’s degree in Science, Engineering or related field
- 2-4 years of operations experience within a cGMP environment in biotech/biopharma
- Leadership experience in manufacturing/quality/engineering
- Experience with Lean Manufacturing or Operational Excellence
- Proficiency with Microsoft Office tools
- Ability to accommodate shift work including evenings and weekends
- Experience with cGMP systems (MES lite, eLIMs, Siemens, SAP) preferred
- Aseptic manufacturing experience
- Strong communication and organizational skills
- Ability to lift 25 lbs and stand for long periods
- Team leadership and ability to develop others
- Knowledge of GMP and FDA guidance
- Proven ability to lead production tasks and cross-functional collaboration
- Experience with batch records and SOPs
- Ability to manage multiple priorities in a fast-paced environment
- Problem solving and analytical skills
- Change management and cross-functional collaboration
- Ability to work in a matrixed environment
- Strong documentation and training abilities
- Leadership in a high-regime manufacturing setting
- Agile Manufacturing concepts
- MSAT knowledge
- Process optimization
- Quality systems familiarity
- Data analytics familiarity
- Training and coaching abilities
- Inclusive leadership mindset
- Cycle of continuous improvement
- Strategic planning and execution
- Technical writing and instruction development
- Good manufacturing practices (GMP) knowledge
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