Kymera Therapeutics

Group Leader, Chemistry, Manufacturing and Controls (Senior Director to Vice President)

Job Description:

We are seeking a talented, independent and experienced CMC professional to lead the Chemistry, Manufacturing and Controls group at Kymera Therapeutics, 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. The successful candidate for this role will be responsible for the development of chemical processes, formulation and analytics for scale-up and manufacturing of drug substance and drug product for its targeted protein degradation small molecule clinical assets. (S)he will lead CMC-related activities across Kymera Therapeutics’ projects including process chemistry, formulation, analytical, and QA. This position will be responsible for all aspects of the manufacturing of drug substance and drug product, from strategy, selection and oversight of CMOs, data analysis, QC/auditing and oversight of study reports, as well as serving as the CMC internal expert for the project teams.

Responsibilities:

  • Oversee CMC related project activities for all small molecule compounds from late-stage discovery through regulatory filings and commercialization
  • Develop and implement strategies to manufacture drug substance including all aspects of drug substance process research, manufacturing, and analytical development including management of milestones, timelines, resources and budgets
  • Lead CRO/CMO strategy including selection and contract negotiation, troubleshooting, data analysis and interpretation, QC/audit, and oversight of study report writing
  • Oversee CMOs for the development of drug product, manufacturing and release of GMP Clinical Trial Materials (CTM) ensuring all appropriate cGMP guidelines and regulations are met
  • Manage drug supply chain in clinical trials
  • Liaise with discovery and preclinical to support physicochemical and formulation work for in vivo studies, and deliver appropriate drug products for different phases of animal and human studies
  • Manage CROs to conduct preformulation characterization and design phase appropriate formulations (from pre-clinical through to Ph III)
  • Ensure appropriate expertise is available to represent the company as the pharmaceutical development expert before U.S. and European regulatory authorities
  • Author, review and approve applicable CMC portions of regulatory filings, process development reports, drug substances, and drug product sections in IND filings
  • Proactively manages risk and drives project related decisions to ensure teams are successful in achieving their goals and team milestones
  • Collaborate with various outsourced CMC functions then eventually build out analytical chemistry, QA/QC and clinical supply functions internally

Qualifications:

  • Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions
  • Technical expertise in oral and parenteral formulations of small molecules
  • Extensive experience in managing US and international CMOs for the manufacture of cGMP drug substance and drug product
  • Experience with filing CMC sections of IND and NDA filings; good working knowledge of relevant FDA and EMEA regulations
  • Comfortable working in a dynamic working environment
  • Rigorous approach to scientific investigation with a sense of urgency to achieve ambitious milestones
  • Excellent interpersonal and communication skills with both internal and external stakeholders
  • Positive but brutally honest in data interpretation
  • Must be a hands-on participant in driving the science and technical aspects of CMC

Key Attributes:

Enthusiastic, goal-driven, collaborative and team-oriented, open-minded, creative, self-aware, excellent communication skills, proven strategic and people leadership skills

Education/Experience:

PhD in chemistry, pharmaceutics, materials science, chemical engineer or relevant discipline with 8+ years of experience in pharmaceutical or biotechnology CMC management of development programs

Email us at careers@kymeratx.com to tell us why you think you’d be a good fit for this position.