Job Title: QC Scientist II, Outsource Testing

Location: Cambridge, MA

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!

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific, we offer the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of the Cell and Gene Therapy field, and we enable our clients to cure genetic, rare, and otherwise untreatable diseases!

How you will make an impact.

The Scientist II will work in GMP QC Laboratories to qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Will perform routine assays and testing including PCR, ddPCR, SDS-PAGE, Western Blot, ELISAs, and cell based assays. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation of commonly used biological reagent and chemical supplies. The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

What will you do?

• Qualify, perform and evaluate the results of qPCR assays, infectivity assays including TCID50, and other assays related to the safety and release testing of intermediate and final biological products (toxicological and clinical materials), and their stability, manufactured by Brammer Bio. These assays must be performed according to written procedures and in compliance with cGMP regulations.
• Qualify, perform and evaluate the results of gel electrophoresis assays, Western blot assays, quantitative protein assays, ELISAs, spectrophotometric assays, cell viability assays, infectivity assays and other assays related to the safety and release testing of intermediate and final biological products (toxicological and clinical materials), and their stability, manufactured by Brammer Bio in the Process Development labs.
• Maintain complete and accurate records of all work performed. Maintain equipment records as required by procedure. Write planned variances, deviation reports, track stability data, write reports etc. in compliance with cGMPs.
• Maintain appropriate in-house assay standards including inventory and database of each standard’s performance in each assay.
• Authors and completes investigations and change controls
• Authors technical documents (SOPs, Work Instructions, Gap Analyses)
• Provides training to junior level employees
• Troubleshoots assay and equipment failures with analysts
• Act as a QC Analytical SME during internal/external audits, risk assessments, and investigations
• Interacts with clients for assay qualifications and onboarding activities
• Onboards new equipment with a cross functional team (procurement, validation)

How will you get here?

• Bachelor’s degree in biological sciences and minimum of 1-3 years of industry experience
• Ability to manage timelines and meet internal/external deadlines
• Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals

Knowledge, Skills, Abilities

• Position requires frequent standing, bending, stopping, and the ability to lift 40 lbs
• Ability to work with strong chemical odors such as Spor-Klenz and bleach
• Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations
• Occasional off shift or weekend hours may be required to meet business needs

Sunday – Wednesday, first shift (0700-1730)

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.