Help to become the foundation for this growing multinational biologics company!
For the purpose of advancing high-caliber molecules closer to the clinic, this biotech is looking to increase our internal process development capabilities. The chosen applicant will oversee the process development and manufacturing operations carried out by contract firms and will provide technical leadership, management, and oversight. The candidate will also work closely with a variety of stakeholders, including those in quality assurance, chemistry, biology, research, and analytical development.
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.
- PhD. in Chemical Engineering, biology, or a closely related discipline with three or more years of experience; MS with six or more years; or BS with eight or 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
- Work Flexibility
- Hybrid Opportunity
- And More……….