Process Development Scientist - Contract - Cambridge, MA
Proclinical is seeking a Process Development Scientist to join a dedicated team.
Primary Responsibilities:
The successful candidate will be required to support the development of advanced novel vaccine programs from preclinical through clinical stages. This role focuses on process characterization, data analysis, and tech transfer to GMP manufacturing.
Skills & Requirements:
- Degree in Biochemistry, Biology, Molecular Biology, Chemical Engineering, or related fields.
- 1+ years of experience in process characterization, development, scale-up, and assay development.
- Proficiency in DOE and JMP software is preferred.
- Experience in protein purification and chromatography is a plus.
- Independent, detail-oriented, and organized with excellent communication skills.
- Ability to work in a dynamic environment as a team player with a strong work ethic.
The Process Development Scientist's responsibilities will be:
- Design and execute experiments to support process development.
- Perform process characterization and development studies.
- Analyze data from process studies.
- Develop new processes or improve existing ones using scientific expertise and literature review.
- Support the tech transfer of developed processes to GMP manufacturing.
- Archive raw and processed data.
- Operate and maintain lab equipment, and train others as needed.
- Document experimental results according to GMP/GLP regulations.
- Author technical reports in collaboration with QA, RA, MSAT, and ARD teams, and assist in submissions to regulatory agencies like the FDA.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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