Principal Scientist/Senior Engineer, CMC Operations Details

Principal Scientist/Senior Engineer, CMC Operations

Jounce Therapeutics - Cambridge, MA

Employment Type : Full-Time

Role / Responsibilities: The Principal Scientist/ Sr Engineer level position in CMC Operations at Jounce Therapeutics will report to the Sr Director of CMC Operations and will be responsible for managing the outsourced development and manufacturing operations of biologics to contract manufacturers. Additionally, this position will include laboratory work. Successful execution of this role requires a strong scientific approach and established expertise in therapeutic process development or manufacturing.
The responsibilities include:

• Support CMC Operations team with CRO/CMO project management
• Assist in planning, writing and reviewing CMC sections across all regulatory submissions 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
• Execution and documentation of experiments in cell line development, bioreactor operation, or purification of biologics in support of technology and drug development
  

Qualifications:

• MS or PhD in Biology, Biochemistry, Bioengineering, Biotechnology, Chemical Engineering or similar
• 8+ years (MS) or 5+ years (PhD) of recent experience in biologics process development, GMP manufacturing, or MSAT role(s)
• Broad knowledge of biologics manufacturing technologies
• 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

• Experience with managing biologics programs at CDMOs preferred
• Experience with FMEAs, process characterization, and process qualification preferred
• Demonstrated ability to function in a collaborative/team-oriented CMC environment preferred

Company Summary: Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the SELECT trial and with Jounce’s broader pipeline. Jounce’s next development stage product candidate, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state. A Phase 1 trial evaluating JTX-8064 is planned to begin enrollment in the fourth quarter of 2020. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.