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Associate I

Company: Thermo Fisher Scientific Inc.
Location: Alachua
Posted on: June 12, 2021

Job Description:

Job Description

Job Title: Associate I

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

Location/Division Specific Information

Alachua, FL - Viral Vector Services Division

How will you make an impact?

The Associate I position will support cGMP manufacturing activities to ensure that Thermo Fisher Scientific Viral Vector Services provides clients with gene therapy products for pre-clinical and clinical use. This position will perform hands on cGMP production of recombinant protein and viral vectors under the supervision of the Upstream Manufacturing Leadership.

What will you do?

This position requires routine hands-on bioprocess manufacturing within a cGMP cleanroom commensurate with the individual's level of technical expertise, training, and qualification strictly following defined procedures. Responsibilities include performing basic bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation, monitoring of processing equipment, processes, and control systems within a GMP cleanroom for the manufacture of viral vectors. In addition, the Manufacturing Associate is expected to keep the GMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, chemical and waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection ready at all times. The Manufacturing Associate will adhere to all Safety and Quality standards of the organization contribute to continuous improvement in the areas of Safety, Quality, and Delivery.

Drug Product GMP Production (90% of time spent on floor)

  • Fully trained on all unit operations associated with the Upstream Manufacturing department .
  • Viewed as an SME/expert in at least one unit operation.
  • Provide critical evaluation of processes, including foresight and thinking ahead.
  • Act as a guide to new employees during onboarding process.
  • Responsible for the upkeep of manufacturing equipment and maintaining an up to date skills matrix.
  • Conduct production suite preparation and/or request necessary components and raw materials, labels, etc. to successfully execute production batch records.
  • Able to assist in all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
  • Performs equipment testing and routine troubleshooting and maintain an up to date skills matrix.
  • Support and conduct other sub-team (Upstream, Downstream, Support Operations) tasks and related production processes, when required.

Prepare and Review Documents (10%)

  • Review and train on manufacturing batch records.
  • Complete preventative maintenance and work notifications tasks on time.
  • Collaborate with quality and PD to review and signoff on executed batch records.
  • Own the executed batch record reconciliation and other production related documents.
  • Working with Supervisors to review, revise, and author Work Instructions (WI)/SOPs/Material Specifications (SPEC).
  • Assist in the optimization of upstream processes for manufacturing.
  • Assist in the technical transfer of processes from Process Development laboratories to manufacturing.

Education/Experience

  • High School Diploma / minimum 1+ years of relevant experience or superior demonstration of skill sets or background
  • Preferred Bachelor's Degree in related field / 0+ year of relevant industry experience

Knowledge, Skills, Abilities

  • Intermediate understanding of Drug Product manufacturing and general Good Manufacturing Practices (cGMP).
  • Excellent communication skills.
  • Desired proficiency in Microsoft Word, Excel, PowerPoint, etc.

Working Hours/Overtime

  • This position will start as a fulltime, Mon - Fri, 40-hour work week
  • Overtime and weekend work will be required as needed.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Keywords: Thermo Fisher Scientific Inc., Gainesville , Associate I, Other , Alachua, Florida

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