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Loyal · 3 weeks ago

Sr. Scientist, CMC Analytical

United States

Full-time

Remote

Mid, Senior Level

$125K/yr - $145K/yr

6+ years exp

Loyal is a clinical-stage veterinary medicine company focused on extending the lifespan and healthspan of dogs. They are seeking a Sr. Scientist, CMC Analytical to provide advanced technical analysis of data generated during product release and stability testing, ensuring robust analytical methods support product quality and regulatory compliance.

BiotechnologyPetVeterinary

Comp. & Benefits

Responsibilities

Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs

Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long-term stability

Provide expert technical input during OOS, OOT, and atypical result investigations, ensuring scientifically sound conclusions

Lead trending of release and stability data across programs, highlighting emerging quality signals and risks

Review and assess data from method development, transfer, qualification, and validation activities

Ensure Quality Control data packages are complete, scientifically defensible, and compliant with cGMP and regulatory expectations

Qualification

Analytical ChemistryMethod DevelopmentQuality ControlCGMP ComplianceRegulatory KnowledgeData InterpretationGoogle WorkspaceProblem SolvingCommunication SkillsAdaptability

Required

A Bachelor's or Advanced degree (master's or Ph.D.) in Analytical Chemistry, Chemistry, Biochemistry or a related field

6+ years of experience in quality control laboratory, analytical or method development, with significant experience with small molecules preferred

Deep and broad knowledge of analytical chemistry in support of small molecule release and stability method development, raw material control, in process control, and characterization

Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations

Proven track record of QC data interpretation and support of regulatory filings

Creative and thoughtful approach to problem solving technical issues

Ability to quickly learn new concepts and processes

Adaptability, creativity and high-performer in risk-assessment and strategic thinking

Detailed eye for logistics and problem solving

Willing to work and comfortable in a fast-paced startup environment with a dynamic team

Clear and polite communication skills

Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.)