We are currently looking for a Process Development Scientist to join our this companies team! In this role, you will focus on the Process Science section in MSAT, whose primary purpose is to carry out laboratory studies using small scale manufacturing models to support root cause investigations and evaluate process improvements. More specifically, this role involves the following:
Duties and Responsibilities
- Manage the creation of reliable cell-lines and cell banks for GMP production.
- Manage biologics manufacturing, scale-up, and tech transfer to support nonclinical and clinical studies
- Use cutting-edge statistical methods, like DOE, to improve early and late-stage processes
- Create CMC documentation for filings with regulatory bodies
- Acquire and keep up-to-date knowledge of current trends and upstream process development technology.
- Ensure thorough, systematic, and complete documentation of all actions taken across all relevant duty areas.
- Ph.D. in Chemical Engineering, biology, or a closely related discipline with 1 or more years of experience; MS with 2 or more years; or BS with 3or more years of relevant work experience
- Experience in clinical-phase and/or commercial cGMP biologics regulations is necessary, as is understanding of product development and clinical manufacturing requirements.
- Managing suppliers and external labs experience is preferable. understanding of how to use and interpret guidelines like ICH, USP/NF, and EP. strong time- and project-management abilities. the capacity to plan and prioritize in a new situation with conflicting priorities in order to achieve deadlines
- Excellent written and oral communication abilities, as well as working independently
- History of scientific rigor and innovation, strong problem-solving and troubleshooting abilities, and the capacity to make positive contributions to discussions
- Competitive 401K opportunities
- Competitive Bonus
- Long Term Incentives
- And More……….