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 innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

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 closely following defined procedures. The Manufacturing Associate will adhere to all Safety and Quality standards of the organization chip in to continuous improvement in the areas of Safety, Quality, and Delivery. The associate identifies and communicates ThermoFIshers values, policies, procedures, and strive to be efficient.

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 follow 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 apply 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?

EDUCATION:

REQUIRED

• High School Diploma

PREFERRED:

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

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

• This position is 10-hour shifts (Friday, Saturday, Sunday, and Monday) 07:30AM to 6:30PM.

• Overtime and weekend work will be required as needed.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and chip in to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

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.

Accessibility/Disability Access

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