Manager, Manufacturing Operations

Company: Vertex Pharmaceuticals Inc (US)
Location: Cambridge
Posted on: September 13, 2020

Job Description:

In 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).Responsibilities include:

• Builds and develops an efficient team of up to 8 direct reports capable of consistently producing clinical product according to cGMP standards.-- Includes hiring, orienting, training and coaching of personnel
• Leads receiving unit component of technology transfer and final process development for Manufacturing team. Includes transfer of method, materials, facility requirements, and documentation
• Ensures cGMP compliance through direct oversight and education of team members
• Manages scheduling of lots in coordination with cross-functional groups.-- Drives resource planning such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities
• Manage team's projects to achieve department and corporate goals, including managing timelines and leading group meetings
• Create, revise and review controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing
• Participate in investigations and CAPA when required
• Receive and manage equipment alarms
• 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 assign as required to meet departmental requirementsRequirements:
  • A minimum of a bachelor's degree with 7-10 years in a process related science; at least 5 years working in process development and/or manufacturing of cell therapy products is strongly preferred.
  • Extensive mammalian cell culture experience
  • Prior GMP 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
  • Experience with 2D cell culture
  • Excellent computer skills including Word, Excel, Project, and OutlookPreferred Experience:
    • Experience with embryonic or induced pluripotent stem cell culture
    • Prior experience with process scale-up
    • Previous experience with electronic Quality Systems

Keywords: Vertex Pharmaceuticals Inc (US), Cambridge , Manager, Manufacturing Operations, Executive , Cambridge, Massachusetts