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

Internal Job Description

Position Overview/Department Description

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: $120,018.18 - $130,832.21 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift

Ability to commute/relocate:

• Framingham, MA 01701: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Manufacturing: 5 years (Preferred)
• SUPERVISOR: 5 years (Preferred)
• Research & development: 4 years (Preferred)
• CAPA: 5 years (Preferred)
• CGMP: 5 years (Preferred)

Work Location: One location

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