Supervisor, Manufacturing Operations 1st shift (1A)

Job Description

General Summary:

The Supervisor, Manufacturing Operations leads first, second, or third-shift manufacturing activities, assigning work in alignment with detailed schedules and production plans. This role is responsible for daily cGMP operations, including equipment setup, assembly, operation, disassembly, and cleaning, while overseeing shift personnel and ensuring compliant, efficient execution of manufacturing activities.

Key Duties and Responsibilities:

• Lead and supervise daily manufacturing operations.
• Assign work to shift personnel based on detailed production schedules and operational plans.
• Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, and cleaning.
• Execute and witness batch record instructions during cGMP operations to ensure accurate and compliant manufacturing documentation.
• Performs real-time on the floor batch record review.
• Interface with cross-functional teams to support facility operations, maintenance activities, and manufacturing objectives.
• Monitor and enforce GMP compliance for all personnel and activities within the Drug Product facility.
• Maintain the facility in an audit-ready state through adherence to procedures, documentation standards, and inspection readiness practices.
• Ensure compliance with SOPs, policies, and work instructions to support safe and successful facility operation.
• Work with QA Document Control to request, receive, and return MBRs for process operations.
• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
• Maintain personal and team compliance with all ongoing training requirements.
• Leading and Attending Tier 0 and Tier 1 meetings.
• Perform other duties and projects as assigned to meet departmental requirements.

Knowledge and Skills:

• Demonstrated leadership behaviors, including supporting team development, serving as a technical lead during triage activities, and recognizing team contributions.
• Leads, develops, and coaches direct reports.
• Effective interpersonal, verbal, and written communication skills, with the ability to work in a dynamic team environment.
• Strong organizational skills with the ability to manage priorities and maintain timelines across multiple projects.
• Sound understanding of relevant drug development activities and standard operating procedures (SOPs).
• Ability to clearly explain why procedures, practices, or technical approaches are being used.
• Solid understanding of the cGMP framework in both development and commercial pharmaceutical drug product manufacturing environments.
• Must be able to remain in a stationary position up to 50% of the time during processing activities.
• Must be able to frequently move about within the cleanroom to perform process tasks.
• Must be able to occasionally move lab equipment and materials weighing up to 50 pounds.
• Work is performed in a manufacturing environment where compressed gases and liquid nitrogen (LN2) are used as part of process requirements.
• Occasional availability to work other shifts may be necessary for onboarding and training.

Education and Experience:

• Bachelor's degree in a scientific, technical or engineering discipline
• 6+ years of experience or the equivalent combination of education and experience
• Prior supervisory or leadership experience preferred
• Prior cell therapy and aseptic manufacturing experience preferred
• Prior POMS MES experience preferred

Work Schedule:

This position follows the following daytime schedule:

• Sunday through Thursday, 7:00 AM to 3:30 PM

Training Period:

New hires will complete an approximately 90-day onboarding and training program on their assigned shift schedule to ensure successful integration into the role.

Training will take place between our Cambridge Facility: 100 Tech Drive and Leiden Center 1 (LC1)

Additional Schedule Information:

Please note that work schedules are based on business needs and may be adjusted or modified as operational requirements evolve. Candidates must be flexible and able to accommodate schedule changes, including shifts, assigned days or hours, as determined by Vertex.

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com