100% On Site • 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.