Jounce Therapeutics

Associate Director, CMC Lead

Job ID
2021-1232
Category
Clinical Development
Job Location
US-MA-Cambridge

Role / Responsibilities

The Associate Director, CMC Lead at Jounce Therapeutics will be responsible for managing the outsourced development and manufacturing operations of biologics to contract manufacturers. 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

Statement

Equal Opportunity Employer

Jounce Therapeutics is an equal opportunity employer and does not discriminate in its employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs.  We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

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 highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with JTX-4014, Jounce’s internal PD-1 inhibitor, or pembrolizumab is currently enrolling patients with advanced solid tumors. 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 INNATE and SELECT trials and with Jounce’s broader pipeline. 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.

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