Executive Director/Senior Director, Process Chemistry

Kymera Therapeutics

Watertown, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 04/16/2021
  • Website: kymeratx.com
  • Company Address: 400 Technology Square, 10Th Floor, Cambridge, MA, 02139

About Kymera Therapeutics

Kymera Therapeutics is a biotechnology company pioneering a transformative new approach to treating previously untreatable diseases. The company is advancing the field of targeted protein degradation, accessing the body’s innate protein recycling machinery to degrade rather than inhibit dysregulated, disease-causing proteins. Powered by a proprietary predictive modeling capability and a game-changing integrated degradation platform, Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients.

Job Description

We are seeking a leader of the process chemistry team to join the CMC drug substance group at Kymera Therapeutics.   The successful candidate will be responsible for providing committed and accountable leadership to Kymera management by delivering well-developed CMC solutions critical to advancing the company’s development pipeline. This role requires a broad-based expertise to help create and implement stage-appropriate solutions for the manufacture of drug substance. Specific responsibilities include synthesis design, process development, specification setting, and optimization of manufacturing processes of new drug substance and related compounds. The position will work closely with the Vice President, CMC, contract development and manufacturing organizations, and key stakeholders in multiple functional areas.

Kymera Therapeutics is a clinical stage biotechnology company focused on advancing the field of targeted protein degradation (TPD), a transformative new approach to address previously intractable disease targets. Kymera’s Pegasus™ TPD platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. Our mission is to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation. Kymera’s goal is to become a fully integrated biopharmaceutical company with a pipeline of novel medicines, with an initial focus on immune-inflammatory diseases and oncology.

In 2021, we plan to continue to grow and strengthen our organizational capabilities to deliver on the potential of inventing a new class of protein degrader medicines for patients. Kymera is rapidly advancing three programs in clinical studies this year. We are also actively advancing a broad pipeline of preclinical programs across a wide variety of diseases, both internally and in collaboration with our partners Sanofi and Vertex Pharmaceuticals.

 

Responsibilities:

  • Provide strategic oversight and leadership on all small molecule and drug development activities including candidate scale-up, raw and starting material sourcing, process development and transfer, clinical stage manufacturing, validation, and quality management.
  • Manage all aspects of the company’s outsourcing activities including selection of outsourcing partners, contract management, budget planning, and the progression of milestones and deliverables.
  • Provide scientific and technical leadership that ensures process development, specifications, manufacture, technology transfer, validation and regulatory outcomes meet or exceed industry and regulatory expectations.
  • Deliver work plans that include process development strategies that translate into deliverables and milestones in a constantly evolving work environment. Develop contingency plans where necessary.
  • Design manufacturing processes that are safe, scalable, robust, cost effective, and environmentally friendly.
  • Apply fundamental chemistry and engineering principles to solve synthesis, analytical, process design, production equipment, and regulatory challenges.
  • Apply industry best practices to address complex issues involving salt, polymorph and particle size attributes, synthesis, reaction kinetics, process safety, analytics, impurity profile management, bioavailability, processibility, stability, and equipment design.
  • Identify critical material attributes and the design space necessary to ensure process robustness in the scale-up and manufacture of clinical, registration stability, and process validation batches.
  • Analyze and summarize complex data sets. Prepare technical reports, publications and oral presentations.
  • Assist in the writing and review of CMC regulatory submissions.
  • Work with cross-functional program teams providing budgets, updates, and project management support required to achieve pre-clinical and clinical development goals and timelines
  • Establish strong and effective communication/collaboration with internal and external development partners.
  • Partner with Discovery Chemistry on synthesis to facilitate candidate nomination into development.
  • Communicate risks and delays to line management/project teams in a timely way
  • Travel domestically and/or internationally to accomplish objectives, when necessary.

 

Qualifications:

  • PhD. in Chemistry or Chemical Engineering plus 15 years, or M.S. plus 20 years, in Drug Substance or Pharmaceutical Development.
  • Strong ability to directly manage Process Chemistry team and lead cross functionally.
  • Comprehensive understanding of drug development and how CMC disciplines integrate and partners with functional areas such as Manufacturing, Risk Management and Quality, Drug Safety, Clinical, Regulatory, Intellectual Property Protection and Contracts.
  • Experience with drug development challenges such as methodology development, route selection, process development, process safety, material characterization, and quality-by-design principles.
  • Strong laboratory skills and knowledge of organic synthesis and pharmaceutical development. Proficient in the use and interpretation of modern analytical techniques, e.g. DSC, TGA, XRD, photo-microscopy, particle attribute characterization, calorimetry, NMR, HPLC, and process automation platforms.
  • Experience working in laboratory and commercial production environments.
  • Experience in working, negotiating with and managing CMO partners.
  • Demonstrated ability to multi-task and be flexible in a fluid work environment.
  • A self-starter with track record of demonstrating initiative.
  • Willingness and ability to work hands-on and with a sense of urgency in a fast-paced, agile environment.
  • Ability to see the overall environment; organize and assimilate data/information; think proactively; prepare contingency plans and future strategies; open to continuous improvement.
  • Ability to manage ambiguity, think critically and make sound scientific and business decisions even when there is limited information. Demonstrated ability to conduct, manage, and communicate risk assessments.
  • Strong communication, collaboration and negotiation skills.
  • Experience in preparing IND and/or NDA submissions
  • Commitment to the values of integrity, accountability, transparency, scientific rigor and drive.     

 

Kymera Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.