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Thermo Fisher Scientific Team Lead QC Bioanalytical 2nd Shift Sun-Wed in Cambridge, Massachusetts

QC Analytical Team Lead

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

Location

Cambridge, MA

How will you make an impact?

The Team Lead will work in the GMP compliant 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?

Position is Sunday - Wednesday 1:00-11:30pm

  • 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.

  • Purify and test molecular biological reagents vital to the continued function of the cGMP QC labs

  • Maintain appropriate in-house assay standards including inventory and database of each standard’s performance in each assay.

  • Authors and execute investigations and change controls

  • Authors technical documents (SOPs, Work Instructions, Gap Analyses)

  • Provides training to junior level employees

  • Coordinates analyst/assay scheduling

  • Works closely with QC Management to develop analyst training plan

  • Leads afternoon MDI meetings

  • Participates in recruiting and onboarding of new analysts

  • 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)

Required Skills

  • Bachelor’s degree in biological sciences is required

  • Minimum of 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

Preferred Skills

  • Master’s degree and minimum of 2 years of industry experience

Special Requirements

  • Ability to gown and gain access to cleanroom areas

  • 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

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.

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