GMP Cell Culture Operations Supervisor (2nd Shift)

Vertex Pharmaceuticals Inc (US)

United States

On-site

USD 90,000 - 130,000

Full time

5 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
Paid time off
Educational assistance
Commuting subsidy
401(k)

Job summary

Vertex is seeking a Manufacturing Operations Supervisor to lead a 2-8 person cell manufacturing team on GMP processes for adherent and suspension cultures. The role focuses on coaching, training, and ensuring cGMP compliance across operations and quality systems.

The incumbent will manage shift-based production, coordinate with cross-functional partners, and drive continuous improvement through SOPs, batch records, and equipment troubleshooting in a cleanroom environment.

Qualifications

  • GMP experience, including lead or trainer roles.
  • Minimum of 3 years cell culture experience in adherent and suspension cultures.
  • 0-2 years direct supervisory experience.
  • Working knowledge of federal GMP manufacturing requirements (21CFR 210,211) and Quality Systems (21CFR 820).
  • Expertise in cell processing and culture technologies for clinical materials production.
  • Experience with bioreactors for cell culture.
  • Proficient with Word, Excel, Project, Outlook and electronic quality systems.

Responsibilities

  • Builds and develops a 2-8 direct report team for clinical product or intermediates per cGMP standards.
  • Hire, orient, train and coach personnel; oversee scheduling with other Manufacturing leadership.
  • Ensure cGMP compliance through education and oversight of team members.
  • Lead project management for direct reports, including timelines and meetings.
  • Collaborate with cross-functional stakeholders on quality systems, CAPAs, change controls, and risk assessments.
  • Create, revise and review SOPs and Batch Records for manufacturing.

Skills

GMP experience
Cell culture
Supervisory experience
Leadership
cGMP
Bioreactors
Quality systems
Computer skills

Tools

Word
Excel
Project
Outlook
Equipment interfaces
Electronic quality systems

Job description

Vertex is seeking a Manufacturing Operations Supervisor to lead a 2-8 person cell manufacturing team on GMP processes for adherent and suspension cultures. The role focuses on coaching, training, and ensuring cGMP compliance across operations and quality systems.

The incumbent will manage shift-based production, coordinate with cross-functional partners, and drive continuous improvement through SOPs, batch records, and equipment troubleshooting in a cleanroom environment.

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