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.
We are rapidly expanding our Device Manufacturing Operations in Providence, R.I.. This role will focus on leading the on-the-floor fabrication of cell encapsulation devices for delivering proprietary cells, including manufacturing of all components and final assembly of the finished device. The Successful Candidate will join the Device Manufacturing Team and work closely with the Device Process Development, Device Quality Control, and Device Quality Assurance Functions, as required.
Initial training will take place during the day. This will be a second shift position in early 2021. Hours and schedule: Monday - Friday 2-10pm.
Reporting to the Associated Director, Device Manufacturing, perform all on- and off-the floor supervisory responsibilities, including training Manufacturing Staff, planning, assigning, and directing work, appraising performance, and ensuring adherence to all Company Policies and Procedures.
Compile monthly Production Schedule, ensuring adherence to requisite demand, and assign and organize appropriate Manufacturing Staff to ensure O.T.I.F. delivery; prioritize and schedule Work Orders and Equipment Time, as required, in a frequently changing environment.
Plan and deliver all Safety, Quality, Compliance, and other “Lean” Initiatives, and ensure upkeep of Manufacturing Areas to allow for a clean, safe, and organized Work Environment.
Manufacture and assemble Medical Devices in an ISO 7/8 Environment, ensuring compliance with c.G.M.P. Procedures and all Cleanroom Practices in each Unit Operation; the Successful Candidate must be prepared to “lead, by example, from the floor”.He / She will have responsibility for day-to-day supervision of the Manufacturing Team.
Compile and review Batch Records in a manner that complies with c.G.M.Ps. / c.G.D.Ps., and all relevant Procedures. Ensure correctness prior to submission to Quality Assurance.
Comply with all Company Policies including Health, Safety, and Environmental Regulations, Personal Protective Equipment Requirements, and Standard Operating Procedures.
Review and train to Work Instructions and other relevant documents on an as-needed basis. Further ensure Training Compliance in the larger Manufacturing Team.
As a Manufacturing Leader, participate in strategic initiatives including, but not limited to, Process Capability Assessments, Process Validation Activities, Root Cause Investigations, Corrective and Preventative Actions, Physical Inventory, Cycle Counts, Variance Investigation and Reconciliation, and other Cross-Functional Activities, as required.
Review and edit all Manufacturing Documentation, including Assembly, Inspection, Test, and Packaging Procedures, and provide feedback as required. Proactively be the “voice” of Manufacturing to other Departments, including Process Development, Quality Control, and Quality Assurance.
AS/BS with at least 7+ Years Manufacturing Work Experience in a Medical
Device and / or other Regulated Environment, including in a Leadership Role; strong familiarity with c.G.M.Ps.. Manufacturing Audit Experience is also required.
Proven ability to monitor Manufacturing Team Work Product, ensuring quality, accuracy, and thoroughness; able to self-motivate and to motivate a larger Team.
Ability to work in a fast-paced environment and multi-task; comfortable with changing Work Environments and priorities.
Manual dexterity to handle tools, and other equipment, of varying sizes.
Excellent verbal and written communication; demonstrable English reading and writing skills.
Flexible to work overtime, extended hours, and weekends, as required.
Familiarity with E.R.P. and Laboratory Information Management Systems.
Experience in assembly of small, intricate Components under microscopic guidance.