Principal Scientist/Associate Director of Cell Line Development
The Principal Scientist/Associate Director level position in Cell Line Development at Jounce Therapeutics will report to the Director of CMC Operations and will be responsible for establishing therapeutic cell line development capabilities.
Successful execution of this role requires a strong scientific approach and established expertise in therapeutic cell line development in CHO.
- Build cell line development capabilities and establish SOPs for stable therapeutic cell line generation capable of meeting industry standard development timelines and regulatory requirements
- Evaluate and in-license cell line development technology/platform that meets Jounce’s business and development needs
- Manage and technically guide CRO/CMO used for cell banking and process development
- Develop template for and author cell line development reports
- Assist in planning, writing and reviewing CMC sections across all regulatory submissions by researching and utilizing information from existing documents and sources including records, reports, protocols, and project team communications to author submission documents in a uniform style and language for regulatory compliance
- Reviews ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations
- Assist in the timely and accurate assembly of responses to inquiries from regulatory agencies on CMC content of regulatory submissions.
- Lead or participate in Project and CMC development teams, as required.
- Establish effective working relationships within Jounce functions, including Research, Regulatory, Quality Assurance and Legal departments
- Support CMC Operations team with CRO/CMO project management, as necessary
Qualifications for the Associate Director:
- MS or PhD in Biology, Biochemistry, Bioengineering, Biotechnology, Chemical Engineering or similar
- 8+ years (MS) or 5+ years (PhD) of recent experience in cell line development in the biopharmaceutical industry
- Direct experience in generating stable CHO clones expressing industry standard levels of therapeutic monoclonal antibody
- Broad knowledge of the stable CHO technologies available for in-licensing
- Ability to analyze product quality data generated by third parties
- Experience in authoring sections of IND or other regulatory filings
- Ability to critically evaluate data from a broad range of scientific disciplines
- Demonstrated track record to successfully work in interdisciplinary teams and managing activities on multiple projects.
- Reasonable approach to risk assessment
- Excellent written/spoken communication skills
- Proficient in flow cytometry
- Experience in cell culture process development and benchtop bio-reactor operation
- Experience in management of out-sourced manufacturing/development activities
- Demonstrated ability to function in a collaborative/team oriented CMC environment
- Experience in vector construction, engineering, and/or optimization