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Manufacturing Technical Services Senior Specialist

Semma Therapeutics

Semma Therapeutics

IT
Multiple locations
Posted on Friday, October 27, 2023

Job Description

The Technical Services Senior Specialist for Change Management and Quality Events is responsible for supporting Vertex Cell and Gene Therapy (VCGT) GMP Operations. The Sr. Specialist will lead change controls and event investigations for GMP Operations. This role aims to support our growing team with owning and implementing Change Controls, event investigations, and formulating corrective and preventive actions (CAPAs) throughout our VCGT Chemistry Manufacturing and Controls (CMC) operations. This role is an on-site position in our Boston location. This role will require approximately 10% support at our Cambridge and Providence locations and some ad-hoc weekend flexibility to support our clinical manufacturing timelines.

KEY RESPONSIBILITIES:

  • Lead change management activities, own change controls (Major/Minor), and CAPAs for key cross-functional projects.
  • Lead, write, and review deviations and investigations for CMC teams.
  • Leverage a change management methodology, process, and tools to create a strategy to support the adoption of the changes required by a project or initiative.
  • Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across VCGT.
  • Identify and collaborate with SMEs ensuring transparent communication and timely resolution of quality events. (Change Control, Deviations, CAPAs).
  • Develop and own a metrics deck focused on key performance indicators that are tracked and disseminated.
  • Provide continuous support to all stakeholders to ensure the successful release and complete oversight of 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.

MINIMUM QUALIFICATIONS:

  • B.A., B.S. in Engineering or related discipline with at least 4 years of relevant experience or M.S. in related field with 2 years of experience or equivalent combination of experience.
  • Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs.
  • Experienced with change management and technical writing in a GMP-compliant environment.
  • Understanding of science and technology of GMP manufacturing environment, preferably Cell and Gene Therapy or related.
  • Excellent verbal and written communication skills.
  • Able to work on multiple projects and manage various priorities and timelines

#LI-SV1 #LI-onsite

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.