Supervisor, Cell Manufacturing Operations

Company: Vertex Pharmaceuticals
Location: Cambridge
Posted on: June 24, 2022

Job Description:

Job DescriptionIn June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat-and even cure-several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.Vertex Cell and Genetic Therapies (VCGT) is designed to accelerate our progress in bringing multiple new transformative medicines to patients in need. We are seeking an outstanding Cell Manufacturing Manager to join our fast-paced and growing team. This full-time, supervisor role will be responsible for leading a team to execute the technology transfer and production of cell therapy products to support VCGT's Phase I/II clinical trials. Clinical materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). Hours and schedule is 1st shift Tuesday through Saturday.
Key Responsibilities:

• Builds and develops an efficient team of 2-8 direct reports capable of consistently producing clinical product according to cGMP standards. Includes hiring, orienting, training and coaching of personnel
• Ensure cGMP compliance through direct oversight and education of team members
• Shares responsibility of scheduling of personnel in coordination with other Manufacturing leadership
• Manages direct reports' projects to achieve department and corporate goals, including managing timelines and leading group meetings
• Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments
• Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing
• Demonstrates 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 assign as required to meet departmental requirementsRequired qualifications:
  • Extensive GMP manufacturing experience required
  • 3-5 years of cell culture experience
  • A minimum of 0-2 years supervisory experience
  • Knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
  • Expertise in cell processing and culture technologies for clinical materials production required
  • Experience with 3-15-Liter scale bioreactors for cell culture required
  • Excellent computer skills including Word, Excel, Project, and OutlookEnvironment:
    • Works in a cleanroom and office setting
    • Must be able to remain in a stationary position 50% during processing activities
    • Frequently move about inside the cleanroom to accomplish process tasks
    • Occasionally moves lab equipment and materials weighing up to 50 pounds.
    • Compressed gasses and LN2 are used in this processCompany InformationVertex 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.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.

Keywords: Vertex Pharmaceuticals, Cambridge , Supervisor, Cell Manufacturing Operations, Other , Cambridge, Massachusetts