Investigation Lead, Manufacturing Technical Operations (contract) 28035
About The Position
The Investigations Lead, Manufacturing Technical Operations (MTO) is responsible for leadership of the MTO – Deviation Team supporting Vertex Cell and Gene Therapy (VCGT) manufacturing operations at multiple sites - Boston Seaport and Cambridge. The Investigations Lead, MTO is responsible for the initial triage and thorough investigation, and cross-functional collaboration of manufacturing and cross-functional deviations for CPI, Drug Substance / Drug Product (DSDP) operations, and support functions. Reporting directly to the Technical Operations Functional Area Investigations Manager or designee, the Investigations Lead will be pivotal in maintaining quality event management. This role will support our growing team by leading root cause analyses, driving impact and risk assessments, and formulating corrective and preventive actions (CAPAs) throughout our VCGT Chemistry Manufacturing and Controls (CMC) operations, gaining alignment with stakeholders including Quality and writing the record content in clear and concise language. Investigations Lead, MTO will drive the records assigned to timely review, comment resolution, and closure . This role is an on-site position in our Boston location. This role will require approximately 10% support at our Cambridge location and ad-hoc weekend flexibility to support our clinical manufacturing timelines.
Requirements
- BS in Science or Engineering (or equivalent work experience)
- 8+ years of progressive experience in biopharmaceutical development and manufacturing.
- 2+ years of experience mentoring and managing staff
- Working knowledge of regulatory requirements, guidelines, and standards that govern cell and gene therapy GMP manufacture.
- Understanding of science and technology of GMP manufacturing environment, preferably Cell and Gene Therapy or related
- Excellent planning and organizational skills, balancing 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.
Nice To Haves
- Knowledge of Medical Device is a plus
Responsibilities
- Lead, write, and review deviations 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.
- Mentors and oversees the work and performance of other investigators
- Provide continuous support to all stakeholders to ensure the 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.
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What This Job Offers
Career Level
Manager
