What are the responsibilities and job description for the Manufacturing Supervisor position at DBSI CONSULTANCY SERVICES?
JOB TITLE:MANUFACTURING SUPERVISOR - SECOND SHIFT
Location: Framingham, Massachusetts, United States
Shift: Sunday-Wed or Wed - Sat, 3:30 PM - 2:00 AM. 10 hours shifts x 4 days a week
Industry: Pharmaceutical / Biotech
Job Category: Research & Development
Key Responsibilities:
The primary accountability of this role is to enable the manufacturing of cell therapy products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing suite in Framingham, MA. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.
Specifically:
The individual will initiate LIRs, OTN and site deviations.
The individual works cross-functionally and in collaboration with internal support departments and Manufacturing suite to develop or update internal policies, procedures or steps, identifies and escalate risks, communicates changes and plan for execution.
Manage, and monitor functional area project and tasks: Campaign support and readiness, MFG process specific change controls, CAPA’s, Laboratory Investigation Reports (LIR), Validation activities.
Key Requirements:
- Advanced technical knowledge of cell therapy manufacturing operations/ process
- Working knowledge and experience with Quality Systems including deviations and change controls
- Excellent communication skills both verbal and written.
Basic Qualifications:
- Bachelor’s degree in sciences or engineering discipline with a minimum of 5 years of industry experience or a master’s degree with a minimum of 3 years of industry experience
- Experience with GMP regulations and cell therapy
- Experience in GMP documentation and compliance
- Ability to operate and thrive in a fast-paced, high-growth environment.
- Strong skills in change management
- Excellent communication skills
Preferred Qualifications:
- Direct experience in cell GMP manufacturing facilities with expertise in CAR-T, NK cell therapy
- Involvement in delivering a cell therapy-based product into clinical development.
Special Instructions:
Shift: Sunday-Wed or Wed - Sat, 3:30 PM - 2:00 AM. 10 hours shifts x 4 days a week
Job Type: Full-time
Salary: $100,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
Schedule:
- 10 hour shift
- Evening shift
Ability to commute/relocate:
- Framingham, MA: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Manufacturing: 5 years (Required)
Shift availability:
- Day Shift (Required)
Work Location: One location
Salary : $100,000 - $130,000