Manufacturing Technical Operations Manager
1 week ago
The Technical Operations Manager for Manufacturing will lead the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at our Boston Seaport location. This role is responsible for the leadership of the team, including immediate triage, investigation, and cross-functional collaboration to resolve manufacturing and cross-functional deviations.
Key Responsibilities:- 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.
- 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.
- Collaborate 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.
- 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.
Flex Designation: On-Site Designated
Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
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