Scientist, Process Development

Work Schedule

Standard (Mon-Fri)

Office

Role:
Scientist, Organic Chemistry

This is a fully onsite role based at our customer’s site in Cambridge, MA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

The Scientist will perform the following activities for the process development of large molecule drug substance. They will be responsible for implementing and optimizing experimental protocols, author scientific reports in the areas of purification, analysis, chemical modification, process development and scale-up of polysaccharide intermediates and vaccines. The scientist will be responsible for implementing and optimizing experimental protocols in the areas of development and execution of downstream processes in different research and development contexts (early development, processability, process development, process understanding, troubleshooting, stability tests, etc).

Completion of process development experiments to support early development, optimization, scale-up and tech transfer for vaccine development programs

• Complete the design and execution of experiments to support process development of novel vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.
• Focus on the development of new processes or improvement of existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.
• Complete analysis and/or characterization of intermediates or drug substances.
• Complete data analysis from process development studies.
• Complete Tech transfer of developed processes to support GMP manufacturing.
• Complete archiving of raw and processed data as per GSK policy.
• Operate and maintains designated lab equipment and train others as needed.
• Complete additional duties and responsibilities as required.
• Complete the documentation of experimental results as per GMP/GLP regulations.
• Complete the authoring of technical reports in collaboration with QA / RA / MSAT / ARD teams at GSK and assist in submission to regulatory agencies such as FDA.

• Bachelor degree in related fields such as Chemistry, Biochemistry or Chemical Engineering with 2-4 years’ experience, or Master degree with 1+ years’ experience.

• Understanding of operations and GMP manufacturing.
• Industry experience with process development, scale-up experience, and assay development preferred.
• Experience in Design of experiments (DOE), quality by design (QbD) principles and JMP software preferred.
• Knowledge in Carbohydrate Chemistry or Synthetic Organic Chemistry preferred.
• Experience in analytical chemistry and familiar with NMR, MS, HPLS, SEC/MALS preferred.
• Independent, detail-oriented, and organized with excellent oral and written communication skills.
• Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.
• Able to maintain written records in the form of laboratory…