Loyal
Principal Scientist, CMC Analytical
$140K–$214K
Remote - US +1 · Remote · Principal · Full-time · Posted Jul 14, 2026
- Location
- Remote - US
Remote - Experience
- 10+ years in analytical method development.
- Education
- Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related field.
About the job
Leads analytical development and quality control for oral solid dosage drug programs, ensuring reliable methods and data support product quality and regulatory submissions.
What you'll do
- Set analytical strategy and lead method development, validation, lifecycle management, and investigations across drug substance and drug product programs.
- Partner with CDMOs and contract laboratories, review and interpret release and stability data, and resolve complex analytical issues.
- Prepare and author analytical data packages and CMC sections for regulatory submissions; mentor junior scientists.
What they ask for
- Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related field.
- 10+ years in analytical method development, including substantial hands-on experience with small-molecule oral solid dosage products.
- Deep knowledge of analytical development and quality control for small-molecule drug substance and drug product, including release and stability methods.
- Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations.
Nice to have
- Sponsor-side pharma experience; animal health or veterinary experience is a plus.
- Experience managing outsourced analytical programs, CDMO relationships, or tech transfer; regulatory filing authorship experience desired.
Pay
$140,000 - $214,000 (base salary; currency not stated)
Tools
HPLC/UPLC, Dissolution, KF, GC, cGMP, ICH/VICH, FDA, EMA
Model-written summary · the original posting is authoritative