Lead QC Scientist

Thermo Fisher Scientific Alachua , FL 32615

Posted 2 months ago

When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

  • How will you make an impact?*
    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.

This position will work in the GMP compliant QC Laboratories to develop, qualify or validate, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Analytical assays performed would support GMP manufacturing activities and release testing.

  • What will you do?*

  • Independently qualify and/or validate assays, and assist in development of the same.

  • Perform Release and Stability testing according to written procedures and in compliance with cGMP regulations.

  • Function as a subject matter expert for relevant assays.

  • Perform routine assays and testing including, but not limited to, PCR (ddPCR and qPCR), agarose gel electrophoresis, SDS-PAGE, ELISAs, immunocytochemistry, and infectivity and reporter gene-based cell assays using insect or mammalian cell lines.

  • Attend internal and client facing meetings to provide technical feedback and support planning activities.

  • Draft SOPs, Test Records, Assay Qualification Protocols and Summary reports and any supporting documents (Reagent Preparations, Equipment SOPs etc).

  • Maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies.

  • Review data generated by reports and solve issues.

  • Troubleshoot and optimize assays under the supervision of the GMP QC Technical Manager.

  • Will mentor Scientists and Lab Associates.

  • Provide input for performance appraisals.

  • Order laboratory supplies and maintain required inventory according to SOPs

  • Perform laboratory and equipment cleaning and preventive maintenance and calibration

  • Perform analytical assays and cell line maintenance

  • Other assigned duties could include sample logging and assisting with shipment preparations

  • How will you get here?*

  • Education:*

  • Master's degree or higher desired, Bachelor's degree in Life Sciences or Chemical/Biological Engineering is minimum requirement

  • Experience: *

  • Minimum of 5-7 years' work experience within the biological and/or pharmaceutical industry.

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

  • Experience writing technical/ scientific documents required

  • ddPCR, HPLC, and/or Capillary Electrophoresis experience preferred

  • Knowledge, Skills, Abilities:*

  • Ability to speak effectively before groups of customers or employees.

  • 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 80,000 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 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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

  • This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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Lead QC Scientist

Thermo Fisher Scientific