Manufacturing Technical Operations Manager
4 weeks ago
Job Summary
The 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 manufacturing and cross-functional deviations. The Manager will also be pivotal in maintaining quality event management and inspection readiness.
Key Responsibilities:
- Lead cross-functional investigations to determine root cause for deviations and analytical investigations.
- Manage a team of approximately 5 extended workforce members.
- Identify and collaborate with Subject Matter Experts (SMEs) for triage, determine immediate actions taken, document impact assessments, lead Root Cause Analysis (RCA), and develop appropriate Corrective and Preventive Actions (CAPAs).
- Own and drive deviations, CAPA, Analytical Investigations (AI), and change control records in our 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.
- Collaborate with SMEs 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.
Requirements:
- 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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