Description

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 Cambridge. This 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

• Bachelor's 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.

#LI-LE1

Pay Range:
$123,600 - $185,300

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:
On-Site Designated

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