Process Development Scientist
5 days ago
PARKING IS ROUGHLY $420/MONTH
Contract duration - 6 month
Job Responsibilities:
- 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 company 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 the FDA
- Complete additional duties and responsibilities as required
Skills & Experience Required:
- Bachelor's degree in relevant field
- Master's degree preferred
- 4+ years of industry experience with process characterization, process development, scale-up experience, and assay development
- Experience in DOE and JMP software
- Similar experience in protein purification and chromatography experience will be considered
- Able to maintain written records in the form of laboratory notebooks
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