Senior CMC Analytical Scientist for Canine Longevity

Quiet Capital; United States; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Home office stipend

Wellness budget

4-day weekends

Unlimited vacation

Paw-ternity leave

Equity options

Job summary

Loyal is seeking a Principal Scientist, CMC Analytical to lead analytical development for oral solid dosage products, ensuring robust methods for release, stability, and regulatory readiness.

You will partner with CDMO partners, manage method lifecycle, and author CMC sections for regulatory filings, mentoring junior scientists, and driving data-driven decisions to support LOY-002 advancement. Expect collaboration in a fast-paced startup setting with strong scientific rigor.

Qualifications

• Ph.D. in Analytical Chemistry or related field with extensive QC or analytical development experience.
• 10+ years in QC lab operations and/or analytical method development for small-molecule products.

Responsibilities

• Lead analytical development and QC strategy for one or more programs, setting method development and lifecycle management.
• Coordinate with CDMO partners as primary technical contact, ensuring adherence to scientific and quality standards.
• Lead API analytical method development, qualification and validation, including forced degradation and impurity profiling.
• Review analytical data (HPLC/UPLC, Dissolution, KF, GC) and resolve complex data issues.
• Identify trends/outliers and translate into risk assessments for leadership.
• Serve as technical lead during OOS/OOT investigations with defensible conclusions.
• Prepare and ensure accuracy of data packages for regulatory submissions (CMC sections).
• Mentor junior scientists and analysts to build team capability.

Skills

Analytical chemistry

Regulatory interpretation

Data interpretation

Problem solving

Cross-functional collaboration

Communication

Education

Ph.D. in Analytical Chemistry

Tools

HPLC/UPLC

Dissolution

KF

GC

Job description

Loyal is seeking a Principal Scientist, CMC Analytical to lead analytical development for oral solid dosage products, ensuring robust methods for release, stability, and regulatory readiness.

You will partner with CDMO partners, manage method lifecycle, and author CMC sections for regulatory filings, mentoring junior scientists, and driving data-driven decisions to support LOY-002 advancement. Expect collaboration in a fast-paced startup setting with strong scientific rigor.