Associate Director/Director of Upstream Process Development
Cellics Therapeutics is seeking an Associate Director/Director of upstream process development to lead the execution of CMC strategies in cell culture process development in support of our drug development and regulatory filings. The candidate will provide strategic, technical, and scientific leadership to the team and support tech transfer to manufacturing.
Essential Duties and Responsibilities:
- Provide technical leadership, management and oversight for the development of stable mammalian cell lines and establishment of cell banks for GMP manufacturing.
- Oversee the development, optimization, and characterization of robust upstream manufacturing processes based upon quality by design (QbD) principles.
- Oversee the tech transfer, scale-up, and/or manufacturing of biologics drug substance to support nonclinical and clinical studies.
- Support risk assessment, investigations, change management, and CAPAs.
- Conduct technical review of manufacturing batch records.
- Prepare CMC documentation for regulatory and/or patent filings.
- Establish and maintain an understanding of current trends and emerging cell line and upstream process development technologies.
- Set clearly defined goals/objectives to ensure delivery of high-quality results.
- Provide clear communication to CMC team, functional teams, and management regarding progress against technical objectives/milestones.
- Ensure well-organized, clear, and complete documentations of all activities across areas of responsibility.
- Ph.D. or M.S. in (bio)chemical engineering, biochemistry, or a closely related field.
- 5+ years of experience for Ph.D. or 10+ years of experience for M.S. in cell culture process development and characterization.
- Proven hands-on experience with mammalian bioreactors is required.
- Experience building relationships and working with CDMOs.
- Familiar with cGMP regulations and ICH guidelines.
- Experienced in tech transfer of a process from development to manufacturing or between manufacturing sites.
- Demonstrated ability to apply engineering principles and statistical analysis, including design of experiments, to solve processing issues and evaluate opportunities for process improvements.
- Experience in preparing CMC documentation for regulatory submissions.
- Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with highly performing colleagues.
- Comfortable executing on multiple projects independently, adaptable and a team-player.
If interested, please email a copy of your CV to email@example.com.