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Job Description

The Manager, Manufacturing Technical Operations (MTO) is responsible for leadership of the MTO Team supporting Vertex Cell and Gene Therapy (VCGT) manufacturing operations at multiple sites - Boston Seaport, Providence, and Cambridge. The Manager, MTO is responsible for building and managing change control ownership center of excellence. This includes all aspects of change control ownership including triage, assessment, planning, change execution, and closure. Reporting directly to the Technical Services Senior Manager, the MTO Manager will be pivotal for maintaining quality event management. This role aims to support our growing team in unplanned deviations including conducting root cause analyses, driving impact and risk assessments, and formulating corrective and preventive actions (CAPAs) throughout our Chemistry Manufacturing and Controls (CMC) operations. This role is an on-site position in our Boston location. This role will require approximately 10% support at our Cambridge/Providence locations and ad-hoc weekend flexibility to support our clinical manufacturing timelines.

KEY RESPONSIBILITIES:

• Manage a team of approximately 3-6 resources responsible for change control ownership.
• Lead, write, and review deviations and investigations for VCGT CMC including Manufacturing, Quality Control, Facilities, Supply Chain, and Material Management.
• Lead cross-functional investigations to determine the 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 an 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 the successful release and complete oversight of related quality events.
• Demonstrate Vertex shared 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 of progressive experience in pharmaceutical development and manufacturing.
• 2+ years of experience mentoring and managing staff.
• Understanding of science and technology of GMP manufacturing environment
• 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 the 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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