Principal Scientist, Analytical Development
Full-timeSeniorAnalytical DevelopmentBiotechnologySmall MoleculePhDMay Not Sponsor
$145K - $215K/yr
Description
As the Principal Scientist, Analytical Development, you will contribute to CMC activities supporting mid and late phase clinical development of Kymera’s small-molecule protein degraders. You will use your scientific expertise to support all CMC analytical development activities, in partnership with CDMOs. Responsibilities include executing development and validation of critical analytical methods, ensuring analytical methods, control strategies, and specifications are robust and validated, characterizing drug substance and drug product-related impurities, managing day-to-day analytical development and testing activities, and collaborating effectively with internal and external stakeholders to deliver on program objectives. Additionally, you will participate in authoring and reviewing analytical sections of late phase regulatory submissions and ensure analytical approaches meet global regulatory expectations.
Requirements
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 required, specifically oral solid dosage. In-depth expertise in late phase test method development and characterization of small-molecule drugs, along with abilities in impurity control strategies including PMIs and nitrosamine impurities. Strong working knowledge of GLP, cGMP, and ICH requirements. Excellent problem-solving mindset, organizational skills, and communication skills are essential. Experience with NDA/MAA filings is a plus.
Kymera Therapeutics
BIOTECHNOLOGY
Small Molecules acting to degrade proteins
LocationMA - Watertown
Open Jobs12
BiotechnologyImmunologyUnknownTargeted Protein DegradationRespiratory
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