Manufacturing Technical Operations Manager
4 weeks ago
The Technical Director will lead the Technical Operations Team in supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Vertex Pharmaceuticals.
This role is responsible for the leadership of the team, including the immediate triage, investigation, and cross-functional collaboration of manufacturing and cross-functional deviations.
The Technical Director will be pivotal in maintaining quality event management and inspection readiness.
This role aims to support the team in conducting root cause analyses, driving impact and risk assessments, and formulating corrective and preventive actions (CAPAs) throughout the organization.
The Technical Director will work closely with subject matter experts to perform risk-based impact assessments and provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.
Key responsibilities include:
- Lead, write, and review deviations and investigations for Drug Substance / Drug Product Manufacturing, Facilities, Supply Chain, and Material Operations.
- Manage a team of approximately 5 extended workforce members.
- 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).
- Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.
Requirements include:
- 4+ years progressive experience in pharmaceutical development and manufacturing.
- ~2+ years of experience mentoring and managing staff.
- ~ 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.
Vertex Pharmaceuticals is an equal employment opportunity and non-discrimination employer.
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Manufacturing Technical Operations Manager
4 weeks ago
Boston, Massachusetts, United States Vertex Full timeJob SummaryThe Technical Operations Manager for Cell Manufacturing will lead the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at our Boston location. The Manager will be responsible for the leadership of the team, including the immediate triage, investigation, and cross-functional collaboration of...
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Manufacturing Technical Operations Manager
4 weeks ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryThe Technical Operations Manager for Cell Manufacturing is responsible for leading the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Boston Seaport location.Key ResponsibilitiesLead, write and review deviations and investigations for Drug Substance / Drug Product Manufacturing, Facilities, Supply...
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Manufacturing Technical Operations Manager
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Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryThe Technical Operations Manager for Cell Manufacturing will lead the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Boston Seaport location. This role is responsible for the leadership of the team, including immediate triage, investigation, cross-functional collaboration, and quality event...
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