DIRECTOR, ANALYTICAL DEVELOPMENT

The Director, Analytical Development will have accountability for the broad range of CMC analytical work within Jounce.  In this role, you will collaborate across the whole organization, including Discovery, Protein Sciences, Quality and Regulatory Affairs.  The position reports directly to the Chief Technical Officer, and will be a fully engaged member of the CMC Leadership Team.  The majority of our work is conducted externally through our network of CMOs/CROs and this role will be responsible for these interactions.  The successful candidate will also provide analytical SME input into the writing and review of regulatory submissions, and take part in Agency interactions.

Responsibilities

  • Work closely with Protein Science colleagues to seamlessly move development candidates from research to CMC stage
  • Develop CMC strategies for the evaluation of development candidates
  • Develop and implement analytical strategies for the development of our pipeline of biologic drug candidates, from candidate nomination through IND- and BLA-enabling activities.
  • Manage and enhance our collaboration with external CMO/CRO partners, and also assess opportunities for bringing work in-house as appropriate.
  • Provide SME input into the writing and review of regulatory submissions, and take part in Agency interactions.
  • Oversee appropriate validation and analytical transfer activities in the appropriate GxP environment.
  • Provide analytical SME input into due diligence initiatives as required.

 

Requirements

  • S. or PhD in analytical sciences and 10+ years’ industry experience of biologics development.
  • Experience in early stage development, and also some experience of late-stage development &/or product approval.
  • Good understanding of GxP requirements and the demands of assay validation.
  • Proven management skills and a demonstrable collaborative mindset.
  • Experience of drug product formulation development

Company Overview

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 the use of our Translational Science Platform, we first focus on specific cell types within tumors to prioritize targets, and then identify related biomarkers designed to match the right therapy to the right patient. Jounce was launched in 2013 with funding from leading life sciences investor, Third Rock Ventures. In July 2016, Jounce announced a global strategic collaboration with Celgene Corporation. This global strategic collaboration, which included a $225.0 million upfront payment and a $36.1 million equity investment, is primarily focused on co‑developing and co‑commercializing innovative biologic immunotherapy treatments for patients with cancer.

 

 

To be considered for this role, please submit your resume to Careers@JounceTx.com with the job title in the subject line of your email.

We are an equal opportunity employer offering a competitive salary and benefits package.

All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.