Manufacturing Technical Services Manager - Deviations (2nd shift)
The Manager, Manufacturing Technical Services (MTS) is responsible for the second shift leadership of the MTS – Deviation Team supporting Vertex Cell and Gene Therapy (VCGT) manufacturing operations at multiple sites - Boston Seaport, Cambridge, and Providence. The Manager, MTS is responsible for the initial triage and thorough investigation, cross-functional collaboration, and same-day closure of manufacturing and cross-functional deviations for Drug Substance / Drug Product (DSDP) operations. Reporting directly to the Technical Services Functional Area Manager or designee, the Manager will be pivotal for 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. Manager, MTS will drive the records assigned to timely review, comment resolution, and closure. This role is a second-shift, 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.
Lead, write, and review deviations and investigations 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.
Provide continuous support to all stakeholders to ensure the successful release and complete oversight of related quality events.
Demonstrate the Vertex Phenotype 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.
BS in Science or Engineering (or equivalent work experience)
5+ 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. Knowledge of Medical Device is a plus.
Understanding of science and technology of GMP manufacturing environment, preferably Cell and Gene Therapy or related.
Understanding of the science and technology of cell and gene therapies.
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.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.