Entry-Level Manufacturing Operator

Portsmouth, NH, United States of America

Our facility specializes in pharmaceutical and biotechnology manufacturing, contributing to the development of life-saving therapies. We are looking for Entry-Level Cell Therapy Operators to join our team and make a difference in the world of healthcare. 

Location: Portsmouth, NH

Type: Full-Time, Direct Hire

Salary: $25.00 to $30.00 per hour

Benefits:

  • Medical, Dental, and Vision insurance
  • Matching 401(k)
  • Paid Time Off (PTO)
  • 12 paid holidays
  • Tuition reimbursement

Shifts Available:

  • Day Shift: 7:00am to 7:00PM, rotation scheduling working every other weekend.
  • Night Shift: 7:00 PM - 7:00 AM, rotation scheduling working every other weekend.

The Cell Therapy Biotechnologist/Manufacturing Associate , will help to provide a safe, controlled work environment in all areas of expertise. Be aware of the site safety objectives and make sure they are communicated and understood. Manufacturing Associate, Level III, will be proficient in an assigned area (i.e. Cell Growth, Drug Product Filling, etc.) and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.). 

Work with customer SMEs to transfer in and maintain customers' processes in production facility.  Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. 

Collaborate with CT Manufacturing Leadership team to incorporate process and operational improvements into new customer processes in manufacturing. 

Collaborate with CT Manufacturing Leadership team to determine equipment and materials the suite will need to purchase in order to run the process. 

May act as a lead role in the absence of the Senior Manufacturing Associate. Potentially lead small teams focused on the tech transfer of customers.  Develop, schedule and deliver quality programs essential to operational readiness.


Key Responsibilities

  • Support the definition and execution of Operational Readiness Activity for the Cell Therapy projects at LPO to include:

    • Set up of manufacturing procedures & collaboration with QA to support CT quality systems aligned with existing operations.

    • Support building & establishing the manufacturing team by participating in the interview, onboarding and training of new colleagues.

    • Support the delivery of clinical & commercial material as required.

  • Lead the definition and execution of Technical Transfer activities for the CT projects at LPO/LWI to include:

    • Development of material requirements, process execution & methods transfer.

    • Developing, defining & executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.

    • Support the development, scheduling and execution of appropriate Safety, Training, Gowning, Material Movement, Visual Inspection, APS, Cleaning, Scheduling, and EM strategies.

    • Support the definition and execution of all activity in compliance with EHS requirements.

    • Enable timely delivery of milestones for the Technical Transfer.

    • Author, review, and approve documentation (batch records, SOPs, WIs, and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.

    • Responsible for interface with customer to coordinate onsite training.

    • Organize and effectively communicate project goals, tasks and milestones of tech transfer project team to CT Management.

  • As project contributor collaborate with CT Manufacturing Leadership Team to ensure.
    • Timely tracking of relevant project metrics
    • Progression of necessary purchase requisitions/orders and tracking through delivery

    • Appropriate interaction with assigned external (customer) and internal stakeholders.


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Entry-Level Manufacturing Operator

Job description

Entry-Level Manufacturing Operator

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