Manufacturing Operations Support & Materials Management Manager; 3rd Shift

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 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

• 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.

• 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,…