Principal Scientist, CMC Analytical

The role

The Principal Scientist, CMC Analytical serves as the analytical lead for oral solid dosage products. This person provides technical analysis of drug substance and drug product data to inform quality decisions and regulatory strategy.

What you will do

• Lead analytical development and quality control strategy for programs.
• Partner with CDMO and contract laboratory partners as the primary technical contact.
• Lead drug substance analytical method development, qualification, and validation.
• Perform review and interpretation of analytical data across release and stability programs.
• Identify trends, shifts, or outliers in complex data sets.
• Serve as technical lead and final scientific authority during OOS, OOT, and atypical result investigations.
• Prepare and author CMC analytical sections of regulatory documents.
• Mentor and provide technical guidance to junior scientists and analysts.

Required qualifications

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or a related field.
• 10+ years in analytical method development with substantial hands-on experience in small-molecule oral solid dosage products.
• Deep and broad knowledge of analytical chemistry in support of small molecule drug substance and drug product analytical development and quality control.
• Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations.
• Proven track record of 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.
• Willing to work and comfortable in a fast-paced startup environment with a dynamic team.
• Clear and concise communication skills.

Nice to have

• Sponsor-side pharma experience strongly preferred
• animal health/veterinary experience a plus
• Prior experience managing outsourced analytical programs (development and/or QC), CDMO relationships, tech transfer desired
• experience authoring analytical sections of regulatory filings desired

Benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends
• Unlimited vacation and paid holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member
• Competitive salary
• Company equity options grant for new hires

About the company

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. The company is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.