Manufacturing Technical Operations Manager

2 months ago

Boston, United States Vertex Full time

Job Description

The Manager for Manufacturing Technical Operations (MTO) is responsible for the leadership of the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Boston Seaport location. The Manager is responsible for the immediate triage, investigation, cross-functional collaboration, of manufacturing and cross functional deviations. The Manager will be pivotal for maintaining quality event management and inspection readiness. This role aims to support our growing team in conducting root cause analyses, driving impact and risk assessments and formulating corrective and preventive actions (CAPAs) throughout VCGT. This role is an on-site position in our Boston location in Seaport with occasional travel to Cambridge required.

The Manager will work one of the following shifts:

  • Sunday – Wednesday 1st shift (9:00 am - 7:30 pm)
  • Thursday – Saturday 1st shift (9:00 am - 7:30 pm)

KEY RESPONSIBILITIES:

  • Lead, write and review deviations and investigations for Drug Substance / Drug Product Manufacturing, Facilities, Supply Chain and Material Operations.
  • Manage team of approximately 5 extended workforce members
  • 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 and drive deviations, CAPA, Analytical Investigations (AI) and change control 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:

  • 4+ years progressive experience in pharmaceutical development and manufacturing.
  • 2+ years of experience mentoring and managing staff.
  • 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.

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