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
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