ProvidenceRecruiter Since 2001
the smart solution for Providence jobs

Manager, Manufacturing Operations 2nd Shift

Company: Vertex Pharmaceuticals
Location: Providence
Posted on: February 21, 2021

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.

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.

Key Responsibilities:

* 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.

Minimum Requirements:

* 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.

Preferred Qualifications:

* Familiarity with E.R.P. and Laboratory Information Management Systems.

* Experience in assembly of small, intricate Components under microscopic guidance.


Keywords: Vertex Pharmaceuticals, Providence , Manager, Manufacturing Operations 2nd Shift, Executive , Providence, Rhode Island

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Physician / Hospitalist / Massachusetts / Permanent / Medical Director
Description: Id : 8698Category : PhysicianLocation/City : MA - LawrenceSalary Range : 0.00 - 0.00 per year
Company: Brine Group Staffing Solutions
Location: Lawrence
Posted on: 02/26/2021

Procurement Manager
Description: Company DescriptionFounded by Eric Lecoq in 1991, we are the preeminent manufacturer of fine French pastries in the US.Intense focus on innovation, investment in state-of-the-art equipment, and an uncompromising (more...)
Company: Lecoq Cuisine
Location: Stratford
Posted on: 02/26/2021

Case Management Nurse - Case Manager - Travel - (CM RN)
Description: Job Description RequirementsCase Management Nurse - Case Manager - CM RN StartDate: 03/15/2021Available Shifts: 12 D Pay Rate: 1913.00 - 2110.00As a valued member of this nursing team, you will care (more...)
Company: Onward HealthCare
Location: Plymouth
Posted on: 02/26/2021

Program Manager
Description: RESPONSIBILITIES:Kforce's East Hartford, CT based client is looking for a Program Manager on a contract basis.Duties: Create and manage long term goals Manage vendor relationships, SOW, and vendor budgets (more...)
Company: Kforce Technology Staffing
Location: East Hartford
Posted on: 02/26/2021

Director of Sales and Marketing
Description: Sunrise Senior Living is an Equal Opportunity Employer. Director of Sales Assisted Living in Plymouth, Michigan - Careers at Sunrise of Northville MI Skip to Main Content Please Enable Cookies to Continue (more...)
Company: Sunrise Senior Living
Location: Plymouth
Posted on: 02/26/2021

Director, SOE Strategy & Resourcing Lead
Description: United States - Connecticut - Groton Pharmaceutical Sciences Small Molecules PSSM develops the formulations and manufacturing processes needed to transform laboratory candidates into potential new (more...)
Company: Pfizer
Location: Groton
Posted on: 02/26/2021

Domino's General Manager in Training - Haverhill - Earn btw $15 - $18 per hour FIRST YEAR (3787)
Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...)
Company: Domino's
Location: Methuen
Posted on: 02/26/2021

Senior Manager, Quality Control Bioanalytical
Description: Company Overview br br CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. (more...)
Company: CRISPR Therapeutics
Location: Framingham
Posted on: 02/26/2021

Sales and Marketing Manager
Description: Classification: Exempt Type: Full-time Reports to: President Date: February, 2021 Location: Lawrence, MA Title: Sales and Marketing Manager The Manager, Sales and Marketing is responsible for developing (more...)
Company: Silverio Insurance Agency
Location: Lawrence
Posted on: 02/26/2021

Project Manager
Description: RESPONSIBILITIES:Kforce's East Hartford, CT based client is looking for a Project Manager on contract basis.Key Tasks: Provide a consistent reporting cadence on project activities Managing changes on (more...)
Company: Kforce Technology Staffing
Location: East Hartford
Posted on: 02/26/2021

Log In or Create An Account

Get the latest Rhode Island jobs by following @recnetRI on Twitter!

Providence RSS job feeds