Kymera Therapeutics · 8 hours ago
Principal Scientist, Analytical Development
Greater Boston
Full-time
Onsite
Senior Level, Lead/Staff
$145K/yr - $215K/yr
7+ years expKymera Therapeutics is a clinical-stage biotechnology company pioneering the field of targeted protein degradation to develop innovative medicines. As the Principal Scientist in Analytical Development, you will lead critical CMC activities supporting the clinical development of small-molecule protein degraders through method development, validation, and regulatory submissions.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Execute development and validation of critical analytical methods, including achiral and chiral HPLC, GC, IC, dissolution, and methods for quantification of potentially mutagenic impurities (PMIs) and nitrosamine impurities
Ensure analytical methods, control strategies, and specifications are robust and validated to support Phase 3 clinical studies, registration, process performance qualification (PPQ), and eventual commercial manufacture
Characterize drug substance and drug product-related impurities
Design and monitor ICH stability programs for drug substance and drug product
Manage day-to-day analytical development and testing activities at CDMOs and contract test labs to ensure that projects remain on track
Contribute to implementing and operating analytical capabilities in Kymera’s internal lab
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 (iii) support investigation of nonconformances (OOS/OOT results, deviations, etc.)
Communicate and present analytical data in CMC meetings and other cross-functional settings
Collaborate effectively with internal and external stakeholders to deliver on program objectives
Participate in authoring and reviewing analytical sections of late phase regulatory submissions (e.g., IND, NDA, MAA)
Support health authority interactions, including responses to agency questions related to analytical methods and controls
Ensure analytical approaches meet global regulatory expectations and inspection readiness standards
Qualification
Required
PhD in Analytical Chemistry or related life sciences field is preferred, but not required, with 7+ years of experience in CMC analytical development
Demonstrated late phase analytical development experience in drug substance and drug product (oral solid dosage experience required)
Experience in developing impurity control strategies, including potentially mutagenic impurities (PMIs) and nitrosamine impurities
In-depth expertise in late phase test method development, method validation/transfer, and characterization of small-molecule drugs
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 testing 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 NDA/MAA filings a plus
Experience providing technical guidance to CDMOs and contract test labs
Experience working cross-functionally among project teams, including internal groups and external CDMOs
Problem-solving mindset, highly organized and detail-oriented, and excellent oral and written communication skills
Benefits
Eligibility for annual bonus
Equity participation
Comprehensive benefits
Company
Kymera Therapeutics
Kymera Therapeutics is a biotechnology company that specializes in the field of targeted protein degradation.
51-200 employees
H1B Sponsorship
Kymera Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (4)
2022 (3)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.96BKey Investors
Biotechnology Value FundAtlas Venture
2025-12-10Post Ipo Equity· $602M
2025-06-26Post Ipo Equity· $250.8M
2024-08-19Post Ipo Equity· $225M
Leadership Team
Nello Mainolfi
Founder, President and Chief Executive Officer
Jeremy Chadwick
Chief Operating Officer
Recent News
2026-01-16
2026-01-11
Company data provided by crunchbase