Senior Manager, CMC Analytics at Loyal

Loyal, a clinical-stage veterinary medicine company, is seeking a Senior Manager, CMC Analytics. This role involves overseeing analytical method development for API and drug products, as well as overseeing testing from product development through commercialization. The Senior Manager will ensure proper controls for API and drug product development and QC testing are in place.

The ideal candidate should have extensive experience with method development for small molecule drug product and API testing, particularly with new chemical entities. They should also have experience overseeing development as a group leader or managing outside labs and be able to critically review all data for potential trends or issues.

Responsibilities:

• Lead analytical development activities, validation, and GMP testing for products in the Loyal portfolio.
• Represent the analytical group in CMC meetings and provide updates on ongoing activities.
• Work with partners on investigations and ensure proper and timely solutions, implementing CAPAs as needed.
• Oversee the development, optimization, and validation of analytical methods at CDMOs for release and characterization of materials.
• Ensure the quality and accuracy of raw data provided by partners.
• Establish specifications for API and drug products in line with current regulations, working with the Regulatory CMC group.
• Stay abreast of industry trends and FDA CVM developments, focusing on innovation in the analytical space.

Requirements:

• A Bachelor’s or Advanced degree in Analytical Chemistry, Chemistry, or a related field.
• A minimum of 10 years of experience in analytical development method development, with significant experience in small molecules.
• 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.
• Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired.
• 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.).

Benefits:

• Full-coverage health insurance
• $1,000 home office equipment stipend
• $1,200/year learning budget
• $250/month wellness budget
• Unlimited vacation and paid holidays
• Company equity options grant for new hires