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*
This position is located in Alachua, FL in the Quality Control Department of a dynamic gene and cell therapy contract development and manufacturing organization.
*How will you make an impact?*
The QC Scientist II 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 ddPCR, 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 cell viability, infectivity assays including TCID50, ddPCR/qPCR assays, Western blot assays, ELISAs, 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. Ability to develop PM/Calibration programs on simple equipment.
* Ability to initiate and assist in investigations for invalid assays or similar.
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 Mon-Fri 8am-5pm shift. Flexibility and overtime may be required on holidays and weekends to support project timelines.
*How will you get here?*
* A Bachelor's Degree or higher in an appropriate area of specialization.
* A minimum of three years of 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.
* Strong aseptic technique, with focus on cell-based assays and cell line maintenance, including cell bank generation and cell line thaw. Must have experience with both adherent and suspension cell lines.
* 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*
* Expertise in at least one relevant, non-compendial analytical or cell-based assay.
* 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
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. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
Apply today! [http://jobs.thermofisher.com](http://jobs.thermofisher.com)
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.