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Director, Cell Therapy Manufacturing Process Development
4 weeks ago
About SCG
SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, HPV, HBV and EBV, and develops a broad and unique pipeline of TCR-based cellular immunotherapy products against infection- associated cancers. With the proprietary GianTCRTM TCR screening platform, in house viral vector production and AutoCellTM, a fully closed and automatic cell therapy manufacturing system, the company covers the entire value chain from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at www.scgcell.com.
Position summary
The candidate will lead and drive the development of a novel cell process development. This role will collaborate closely with multiple cross-functional teams including Analytical Development, Research, Supply Chain and External Manufacturing to coordinate critical deliverables. The individual will also maintain a focus on innovation and process improvements to develop next generation cell therapy manufacturing processes.
Core responsibilities
- Define process development strategy in close collaboration with the CMC leads
- Lead the execution of the cell therapy process
- Mentor, train, and motivate a group of engineers and research associates to plan, execute and analyze experiments
- Provide expert technical opinions to justify process development decisions
- Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
- Evaluate new bioprocess technologies and implement process advancements for introduction into a GMP manufacturing environment
Role requirements
- PhD. in Chemical, Pharmacology, Biological or Biomedical Engineering plus 8 years of industry experience or equivalent.
- At least 5 years of progressive experience in cell therapy process development, preferably with clinical and commercial stage
- Experience designing and scaling key cell therapy unit operations, especially T cell cultures within bioreactors
- Strong track record of applying fundamental engineering and scientific principles to process design, modeling, and characterization
- Well versed with cGMP requirements and working in a regulated environment
- Effective collaborator with an agile mindset to thrive in a fast-paced, multi-site, team-oriented organization
- Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
Tell employers what skills you have
Cell
Modeling
Manufacturing Processes
Supply Chain
GMP
Clinical Development
Bioprocess
Biomedical Engineering
Biotechnology
PMO
Unit Operations
Characterization
Teamoriented
Pharmacology
Manufacturing
Cell Therapy
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