Manager, Manufacturing Technical Operations

The Manager, Manufacturing Technical Operations (MTO) is responsible for triage and investigation team leadership for cell manufacturing operations, quality control and production support areas. The MTO Manager is responsible for leading MTO activities on the Wednesday to Saturday shift focusing on deviation center of excellence but also includes risk assessment ownership including drafting, facilitating cross-functional team, initiating, and driving follow-up mitigations and report closure. Reporting directly to the MTO Associate Director, the MTO Manager will be pivotal for maintaining quality event management and promoting compliance for both shifts of external workforce (EWF) team members on this Wednesday to Saturday rotation. This role aims to support our growing team in unplanned deviations including conducting root cause analyses (RCA), driving impact and risk assessments and formulating corrective and preventive actions (CAPAs) throughout our Chemistry Manufacturing and Controls (CMC) operations. This is an on-site position in our Boston location. This role may require up to 10% on the floor support to aid investigations and conduct operator interviews. Hours are 9am-7:30pm Wednesday to Saturday and may require ad-hoc schedule flexibility to support our clinical manufacturing timelines.

KEY RESPONSIBILITIES:

• Lead, write and review deviations and investigations for VCGT CMC including Manufacturing, Quality Control, Facilities, Supply Chain and Material Management.

• Act as shift lead for Wednesday to Sunday shift and provide weekend MTO leadership on Saturdays.

• Accountable for assigning and guiding quality event workload forEWF team of approximately 3-6.

• Lead cross functional investigations to determine root cause for deviations and analytical investigations.

• Identify and collaborate with SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, and develop appropriate CAPAs.

• Own deviations, CAPA, Effectiveness Check (EC) and Analytical Investigations (AI) records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.

• Lead cross functional meetings and regularly update stakeholders on the status of ongoing investigations, ensuring transparent communication and timely resolution.

• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.

• Collaborates with subject matter experts to perform risk-based impact assessments.

• Provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.

• Demonstrate the Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

• Other duties and projects as assigned to meet departmental requirements.

MINIMUM QUALIFICATIONS:

• 5+ years progressive experience in pharmaceutical development and manufacturing.

• 2+ years of experience mentoring staff.

• Understanding of science and technology of GMP manufacturing environment, preferably Cell and Gene Therapy or related.

• Understanding of the science and technology of cell and gene therapies.

• Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.

• Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.

• Experienced with technical writing and performing event investigations in a GMP-compliant environment.

• Excellent verbal and written communication skills.

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