Vertex Pharmaceuticals

Job Description

GENERAL SUMMARY:

The Sr. Specialist, Manufacturing Technical Operations (MTO) is responsible for ownership of deviations and CAPAs for MTO Team supporting Vertex Cell and Gene Therapy (VCGT) manufacturing operations at our Boston, Cambridge, and Providence sites. The Sr. Specialist, MTO is responsible for owning, planning, and driving all aspects of deviations in the electronic quality management systems (eQMS) as part of the MTO compliance center of excellence. This role also aims to support our growing MTO team with ownership and support of corrective and preventive actions (CAPAs), change controls and analytical investigations. This position will enhance efficiency by ensuring best practices are implemented and mentoring junior MTO staff. This role is an on-site position in our Boston location. This role is a flex/second shift position that requires up to 25% support at our Cambridge and Providence locations and ad-hoc weekend flexibility to support our clinical manufacturing timelines.

KEY DUTIES AND RESPONSIBILITIES:

• Triage unplanned deviations in real-time with cross-functional team to determine immediate actions taken to support real time release.
• Lead, write and review deviations for VCGT, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
• Identify and assemble proper SMEs for root cause analysis working sessions for unplanned deviations.
• Own and track quality events including deviations, analytical investigations for VCGT CMC including Manufacturing, Quality Control, Facilities, Supply Chain and Material Management.
• Mentor junior MTO staff including resident contract resources by peer reviewing draft deviations and CAPAs prior to quality review.
• Support other MTO teams as needed including change control, risk assessments, training and documentation. Ensure all timelines and due dates are achieved.
• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.
• 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.

EDUCATION AND EXPERIENCE:

• BS/MS in chemical, mechanical, or material science engineering.
• 4+ years progressive experience in pharmaceutical development and manufacturing.
• 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, 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.
• Excellent verbal and written communication skills.

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Company Information

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.