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Executive or Senior Director, Formulation Development

Kymera Therapeutics

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has Ebeen recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

  • PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
  • COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
  • BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll contribute:

We are seeking an Executive/Senior Director to join our Formulation Development team and lead mid-to-late-stage drug product development and manufacturing activities. The successful candidate will be responsible for leading drug product efforts for a high priority program progressing into Phase 2 and later stages of development. The candidate will also serve as the CMC leader for the program and drive development and execution of the CMC strategy and represent CMC on the project core team.

This key position will interact with all disciplines of drug development in addition to CMC, including pre-clinical, clinical, and regulatory areas. Experience working directly on drug product development of oral small molecule agents, leading CMC teams, and contributing to the filing of one or more INDs/NDAs is required.

  • Lead late-stage formulation development efforts to support clinical studies in Phase 2 and beyond, and develop optimal commercial dosage form
  • Design, plan and execute DP manufacturing strategy for late-stage clinical studies and commercialization
  • Manage and coordinate outsourcing efforts at external CROs to ensure high quality and on-time execution
  • Lead a high-functioning CMC team on a key program in developing the overall CMC strategy and driving to successful execution
  • Author and oversee the preparation of technical reports, data summaries and CMC documents required for regulatory submissions. Plan and author communications/responses related to drug product with regulatory authorities
  • Design and execute process characterization activities to identify critical process parameters.
  • Author/review change controls, deviations and CAPAs as required, to ensure Good Manufacturing Practices are followed
  • Support the early formulation development team in assessing development candidates, for smoother transition into late stage development
  • For the assigned project(s), represent formulation development and/or CMC in core teams, external collaborations, CROs/CMOs, and cross-functional teams
  • Develop and maintain strong working relationships with key stakeholder groups in R&D

What skills and experience you’ll bring:

  • degree in Pharmaceutics, Chemical Engineering, or Pharmaceutical sciences with at least 10 years relevant pharmaceutical industry experience
  • In-depth understanding of pre-formulation, clinical formulation, biopharmaceutics principles required to progress a molecule through clinical development and registration
  • Manufacturing and outsourcing experience, particularly in oral dosage form development
  • In-depth understanding of critical process parameters characterization studies and impact on critical quality attributes
  • Experience in drug product development with a focus on late stage optimization, process characterization, registration and validation
  • Experience with working in and leading cross-functional CMC teams, strong knowledge of process and analytical development and a working knowledge of other areas of drug development
  • In-depth familiarity with phase based GMPs and manufacturing compliance requirements, regulatory guidances and expectations
  • Ability to effectively manage cross functional, complex and evolving projects, influence stakeholders without direct authority, and network across the organization
  • Excellent communication, problem solving, critical thinking, and organizational skills

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

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Confirmed 6 hours ago. Posted 30+ days ago.

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