Manufacturing Operations Support & Materials Management Manager (3rd Shift, 410)

Job Description

The Manufacturing Operations Support & Materials Management Manager is the accountable off-shift superintendent for cGMP cleaning and materials management support for cell manufacturing sites located in Boston and role provides general oversight for Materials Management and Manufacturing Support functions. The Manager will partner with with Manufacturing Operations Quality Assurance Facilities and Vertex managed service partners for troubleshooting and resolving issues as well as escalations to leadership for direction as necessary. As the off-shift superintendent the Manager ensures compliant operations cGMP cleaning and materials management through proactive management. This leadership position monitors service level agreements with managed service partners and leads process confirmation for key functions.

The Manager will work 3rd Shift on a 4/10 schedule (40 hours/week) with the following hours:

• Sunday through Wednesday 6pm through 4am; OR

• Wednesday through Saturday 6pm through 4am

Responsibilities

• Lead second and overnight shift operations in support of cGMP Manufacturing.

• Directly accountable for GMP cleaning and Material Management activities across all designated Vertex sites ensuring execution of daily plans and compliance with GMP requirements.

• Provide oversight for drug product pack and label operations. Serve as technical SME for serialization equipment and drug product pack-outs.

• Act as superintendent for assigned shift serving as escalation lead for materials management and cleaning operations. Provide shift oversight to outsourced functions.

• Oversee the inventory management of cleaning agents gowning process aids and materials to ensure uninterrupted operations.

• Monitor and enforce adherence to aseptic and cleanroom protocols to maintain contamination control.

• Provide SME support for Oracle and inventory reconciliation during assigned shifts.

• Point of escalation for unplanned requirements during off hours operations with specific accountability for material control and availability to ensure uninterrupted operations.

• Serve as liaison between managed service partners and internal stakeholders.

• Subject matter expert for quality events related to cleaning operations and materials management including deviations CAPAs corrective actions (CAs) and impact assessments (IAs).

• Develop revise and implement SOPs and work instructions to reflect evolving regulatory and operational best practices.

• Maintain an audit-ready facility by proactively identifying and resolving compliance gaps conducting walkthroughs and ensuring timely documentation closure and MES exception handling.

• Lead and support continuous improvement initiatives that enhance cleaning efficiency compliance and staff engagement.

Required Qualifications

• Bachelors degree in life sciences engineering or related field or equivalent combination of education and experience (minimum 3 years in cGMP biopharmaceutical operations).

• 2 years leadership and people management experience in a regulated environment. Prior experience in a cell and gene therapy manufacturing facility highly preferred.

• 5 years experience in aseptic manufacturing or cleanroom cleaning within a GMP-regulated pharmaceutical or biotech manufacturing environment.

• Strong understanding of GMP compliance aseptic practices material control and cleanroom procedures.

• Previous drug product manufacturing experience supporting production materials management facilities and cleanroom operations

• Experience with electronic systems including MES (Manufacturing Execution System) ERP (Enterprise Resource Planning) and Veeva (Quality Document Management System).

• Familiarity with Annex 1 ISO 14644 or related cleanroom standards.

• Demonstrated ability to lead investigations manage vendor relations and drive process improvements.

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 Vertexs 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 persons 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