Job Title: Quality Control Scientist

Requisition ID:

Location: Alachua, Florida

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 Scientist 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 analytical assays. The Scientist will also develop, qualify and conduct assays including qPCR, ELISAs, SDS-PAGE, cell based assays including infectious titers and chemistry based assays such as pH, osmolality, etc.

What will you do?

• Qualify, perform and evaluate the results of qPCR assays, Western blot assays, ELISAs, cell viability, infectivity assays including TCID50 and other assays related to the safety and release testing of intermediate and final biological products. These assays must be performed according to written procedures and in compliance with cGMP regulations.
• Maintain complete, contemporaneous and accurate records of all work performed. Maintain equipment records as required by written procedure. Write planned variances, deviation reports, track data and write reports in compliance with cGMPs. Assist with document revisions for SOPs and Test Records.
• Ability to perform tasks within the lab without direct supervision and then train others on procedures for which you are qualified.
• Other assigned duties include managing reagents and material supply, maintaining equipment via cleanings, calibrations and preventive maintenance. Maintaining appropriate in-house assay standards including inventory and databases with other duties as assigned by supervisor.

Analytical assays performed would support GMP manufacturing activities and release testing as well as stability studies for the Process Development department. 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?

Education

• A Bachelor’s degree in Life Sciences or Chemical/Biological Engineering.

Experience

• A minimum of one year relevant work experience with preference for candidates that have previously worked in a cGMP compliant QC laboratory performing biological assays such as those listed above.
• Ability to read, interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals with the ability to use the information to create job specific standard operating procedures
• Laboratory documentation, reports, and correspondence

Knowledge, Skills, Abilities

• Skilled with electronic information management systems (LIMS, electronic lab notebooks, etc) and electronic organizational skills using Microsoft Excel, Smartsheet 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.

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.