Full-Time
Associate Director
Posted on 1/17/2023
Develops small molecule therapeutics to degrade disease-causing proteins
Senior
Belmont, MA, USA
- PhD in analytical chemistry (preferred), organic chemistry, or a related life sciences field with 7+ years of experience in CMC analytical development
- Demonstrated analytical development experience in both drug substance and drug product (oral and parenteral), including establishment of specifications and analytical control strategies for starting materials, intermediates, and final products
- Experience developing impurity control strategies, including for potentially mutagenic impurities (PMIs)
- In-depth expertise in test method development, method qualification/transfer, and characterization of small-molecule drugs during preclinical (GLP toxicology) and early-phase clinical development
- Chiral HPLC method development and qualification experience
- Broad analytics expertise with widely employed techniques - HPLC (UV, RID, ELSD, CAD), GC, MS, NMR, XRPD, DSC/TGA, KF, particle size analysis, and dissolution
- Knowledgeable of compendial test methods (USP/EP) used for DS and DP testing
- Capable of designing, implementing, and managing cGMP stability studies for DS and DP at external labs
- Strong working knowledge of GLP, cGMP, and ICH requirements
- Prior experience writing analytical sections in IND/IMPD filings
- Problem-solving and troubleshooting skills
- Demonstrated leadership, planning and organizational skills
- Extensive experience providing technical leadership to CDMOs and contract test lab partners
- Experience with working cross-functionally among project teams, including internal groups and external CDMOs
- Exceptional oral and written communication skills geared to all levels of the organization
- Proficiency with MS Office and document sharing and archival platforms
- Provide technical leadership for all CMC analytical activities, including specification setting, test method development and qualification, and outsourced QC testing for drug substance and drug product
- Lead cross-functional collaborations to establish phase-appropriate specifications and analytical control strategies for starting materials, intermediates, drug substance, excipients, and drug product
- Lead the characterization of DS and process and product-related impurities, including analytical oversight for solid-state characterization studies
- Accountable for design, development, and phase-appropriate validation of critical test methodologies, including chiral and achiral HPLC, GC, IC, in-vitro dissolution, and techniques for quantification of potential mutagenic impurities (PMIs)
- Establish and maintain outsourced ICH stability programs for drug substance and drug product
- Prepare/review request-for-proposals (RFP) and manage day-to-day analytical development and testing activities at CDMOs and contract test labs to assure that projects remain on-track
- Partner closely with CMC colleagues and QA to (i) write or review test methods, SOPs, analytical data summaries (CoT/CoA), protocols, and technical reports, (ii) critically review, trend, and interpret analytical testing results, and (ii) support investigation of nonconformances (OOS/OOT results, deviations, etc.)
- Communicate and present analytical data in CMC meetings and other cross-functional settings
- Author CMC analytical sections in INDs and other regulatory filings
- Collaborate effectively with internal and external stakeholders to deliver on program objectives
Kymera Therapeutics stands out as a pioneering biopharmaceutical company, utilizing its proprietary Pegasus platform to design small molecule protein degraders that target disease-causing proteins, a method that holds significant advantages over existing therapies. The company's focus on previously inadequately drugged biological pathways, particularly in immunology-inflammation and oncology, demonstrates its commitment to addressing unmet medical needs. With a culture driven by the invention of transformative medicines, Kymera is reshaping the approach to treating diseases where traditional modalities have fallen short.
Company Stage
IPO
Total Funding
$879M
Headquarters
Watertown, Massachusetts
Founded
2016