Manager, Manufacturing Operations 2nd Shift
Company: Vertex Pharmaceuticals
Posted on: February 21, 2021
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 -
* 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
* 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
* 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
* 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
* Excellent verbal and written communication; demonstrable English
reading and writing skills.
* Flexible to work overtime, extended hours, and weekends, as
* Familiarity with E.R.P. and Laboratory Information Management
* Experience in assembly of small, intricate Components under
Keywords: Vertex Pharmaceuticals, Providence , Manager, Manufacturing Operations 2nd Shift, Executive , Providence, Rhode Island
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