Reporting to the VP of CMC, the Senior Director of Cell Line Development will be accountable for the development of fully traceable, regulatory compliant clonal stable GMP cell lines producing novel therapeutic fusion proteins. You will lead a team and expand cell line development projects to help advance novel cancer therapies into human clinical studies. Furthermore, you should be able to work independently, mentor junior associates, and provide insight to improve processes and communicate results in development team meetings.
- Manage activities involving the development of GMP cell lines at Shattuck Labs and CDMOs.
- Develop and establish an industry-leading Cell Line Development (CLD) capability to produce ARC molecules, hetero-dimeric fusion proteins, and future advanced therapeutics (stable transfections, pool and clone generation, research cell banks, cell age stability studies, genetic characterization).
- Support Research in developing novel protein-expressing plasmids/vectors and cell lines for advancing Shattuck science and manufacturing initiatives.
- Lead initiative to develop novel mammalian 'host' cell lines with attributes desirable for the production of these novel therapeutics.
- Collaborate with other CMC functions to achieve project goals and timelines.
- Author or review CLD documentation and other technical reports ensuring appropriate quality of documentation to support regulatory filings.
- Contribute to relevant CMC sections in regulatory filings.
- Publish or present scientific findings in peer-reviewed journals or conferences.
- Mentor junior associates and scientists.
Qualifications and Requirements:
• The ideal candidate will be experienced in some of the following:
- Single cell cloning
- Clone Pix
- Ambr 15
- Cell line expansion
- Cell culture and bioreactor systems for mammalian protein production
- Bioreactor harvest
- A successful candidate must possess exceptional attention to detail, organizational, interpersonal, and communication skills, and demonstrate critical thinking and problem-solving ability.
- Must have the ability to multi-task to meet critical deadlines and the independent initiative to solve interdisciplinary problems.
- Candidate must be sharp, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.
- Must enjoy working in collaboration with others and small teams to achieve goals through effective building of relationships with co-workers.
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