Associate 1, Support Operations Manufacturing

Thermo Fisher Scientific Inc. Alachua , FL 32615

Posted 2 months ago

Job Description:

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

The Manufacturing Associate is member of the GMP Manufacturing department in Alachua, Florida whose mission is to deliver a consistent and reliable supply of quality released viral vector drug substance and/or drug product that meets regulatory and internal Quality and Safety standards.

How will you make an impact?

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 of performance, monitoring of processing equipment, processes, and control systems within a GMP cleanroom. The Manufacturing Associate is expected to keep the GMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, 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.

What will you do?

  • Perform cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule

  • Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards

  • Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards

  • Ability to learn biopharmaceutical manufacturing processes including but not limited to: the use of autoclave, buffer preparation, cleaning, stocking, disinfectant prep, decontamination, fumigation, waste management, equipment maintenance, materials movement, staging, etc.

  • Adheres to the production schedule ensuring on-time delivery and efficient production logistics

  • Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)

  • Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities

  • Other duties as assigned

How will you get here?


  • High School Diploma


  • Associate Degree in Life Sciences, Engineering, or Biotechnology or certificate program and one to three years' industry related experience


  • Manufacturing experience preferred

  • Cleanroom experience preferred

  • Experience using SAP preferred

  • Autoclave experience preferred

  • Buffer or media preparation experience preferred

Knowledge, Skills, Abilities

  • Strong interpersonal and communications skills; written and oral

  • Solid understanding of applicable regulatory requirements

  • Strong working knowledge of Microsoft Office

  • Ability to deliver high quality documentation paying attention to detail

  • The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

Work Hours: Monday through Friday, 3:00 PM to 11:30 PM on a FLEX schedule. Overtime, weekend and holidays required to meet project timelines as necessary.

At Thermo Fisher Scientific, each one of our 70,000 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.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Control Associate I

Thermo Fisher Scientific Inc.

Posted 7 days ago

VIEW JOBS 11/27/2020 12:00:00 AM 2021-02-25T00:00 Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. 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. Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need. We work in close collaboration with each client's team to deliver successful programs. Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases. The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients. This exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market. Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we'll enable breakthroughs in science that improve patients' lives and bring hope for a healthier world! How will you make an impact? The QC Associate will work in the GMP compliant QC department to support GMP testing of biopharmaceutical products being manufactured at VVS under contract. The position includes performing routine lab activities such as cleaning, inventories, equipment preventive maintenance and calibrations, ordering supplies, and executing some analytical assays. What will you do? * Maintains and ensures safe laboratory environment and work practices according to SOPs * Perform laboratory and equipment cleaning and preventive maintenance and calibration * Conducts routine tasks and sample analyses to support in process and product testing * Other assigned duties could include sample logging, reagent preparations, and assisting with shipment preparations Analytical assays performed would support GMP manufacturing activities and release testing. The assays could include Appearance, pH, Osmolality, Conductivity and maintaining cell lines used in QC laboratories. This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines. How will you get here? * * A high school diploma * * Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals * Laboratory documentation, reports, and correspondence Knowledge, Skills, Abilities * Electronic organizational skills using Microsoft Excel or other planning tools * Ability to communicate/work in a high pressure/high paced environment * Ability to multi-task and function effectively as a member of a team 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. Thermo Fisher Scientific Inc. Alachua FL

Associate 1, Support Operations Manufacturing

Thermo Fisher Scientific Inc.