Senior Scientist, CMC Analytics (Small Molecules)

Loyal; United States; Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Full-coverage health insurance

Home office stipend

Learning budget

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, driving method development, validation, and lifecycle management to ensure robust quality and regulatory readiness.

You will partner with CDMOs, review analytical data (HPLC/UPLC, dissolution, KF, GC), mentor junior scientists, and author analytical sections of regulatory filings, reporting to the Senior Director, Analytical Development.

Qualifications

• Ph.D. in analytical chemistry or related field with extensive post-PhD experience.
• 10+ years in analytical method development for small-molecule oral solid dosage products.
• Experience with regulatory filings and cGMP would be advantageous.

Responsibilities

• Lead analytical development and quality control strategy across programs.
• Coordinate with CDMO and contract labs as primary technical contact.
• Develop/validate APIs and drug product analytical methods including forced degradation and impurity profiling.
• Review and interpret analytical data across release and stability programs.
• Own and author analytical sections of regulatory submissions (CMC).
• Mentor junior scientists and analysts.

Skills

Analytical method development

Data interpretation

Regulatory filings

HPLC/UPLC

Dissolution

KF

GC

cGMP compliance

Education

Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or related field

Tools

Regulatory authoring tools

Job description

Loyal is seeking a Principal Scientist, CMC Analytical to lead analytical development for oral solid dosage products, driving method development, validation, and lifecycle management to ensure robust quality and regulatory readiness.

You will partner with CDMOs, review analytical data (HPLC/UPLC, dissolution, KF, GC), mentor junior scientists, and author analytical sections of regulatory filings, reporting to the Senior Director, Analytical Development.