Sr Scientist - Analytical Development
$120,000–$168,000 year
HybridIrvine, California, United States
Job Summary
Develop and execute analytical development plans for clinical-stage drug substance and drug product programs, designing, validating, and transferring methods for drug substances, products, and excipients in compliance with ICH, FDA, and cGMP requirements. Lead analytical risk assessments, control strategy development, and root-cause investigations for OOS/OOT issues while providing scientific oversight to external laboratories, CROs, and CDMOs. Interpret stability data to support specification setting and regulatory submissions, authoring technical documents for IND, CTA, and NDA filings. Collaborate cross-functionally with Regulatory, Quality, and Manufacturing teams to ensure analytical activities align with program objectives. The position reports directly to the Director, Analytical Development, requires a hybrid work environment in Irvine with up to 30% travel, and includes stock equity and comprehensive benefits.
Required Qualifications
- PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline
- 4+ years of relevant pharmaceutical or biotechnology industry experience
- MS degree with 8–12 years of relevant pharmaceutical or biotechnology industry experience
- Demonstrated experience supporting analytical development activities for Phase I–III clinical development programs
- Experience managing CROs, CDMOs and external analytical laboratories
- Proven experience authoring and reviewing analytical CMC documentation for regulatory submissions
- Strong understanding of Quality by Design (QbD), risk-based analytical development, and control strategy development
- Working knowledge of ICH, compendial, FDA, cGMP, and CMC guidelines and industry best practices
- Travel will be required, up to 30%, including international travel
- The position will be based in our beautiful Irvine office
Desired Qualifications
- Experience with small peptides
- Experience with sterile, ophthalmic, injectable, or other complex dosage forms
- Experience with extractables/leachables, elemental impurities, forced degradation, characterization studies, and bioanalytical methods
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