Scientist in Cambridge, MA

100% On Site

Duties:

• Perform design and execution of experiments to support process development of advance novel vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.
• Perform process characterization / process development studies for the MAPS program
• Perform data analysis from process characterization / process development studies
• Support the development of new processes or improve existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.
• Support Tech transfer of developed processes to support GMP manufacturing.
• Complete archiving of raw and processed data as per CLIENT policy
• Operate and maintains designated lab equipment and train others as needed.
• 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 CLIENT and assist in submission to regulatory agencies such as FDA.
• Complete additional duties and responsibilities as required.

Education and Experience:

• Masters/Bachelors in related fields such as Biochemistry/Biology/Molecular Biology/Chemical Engineering with 1+ years' experience.
• Industry experience with process characterization, process development, scale-up experience, and assay development preferred.
• Experience in DOE and JMP software preferred.
• Similar experience in protein purification and chromatography experience will be considered.
• 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 notebooks.

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