Senior Biologics Analytical Lead, Drug Development

HonorVet Technologies; San Clemente (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

HonorVet Technologies is seeking a Sr. Scientist II, Biologics in California to lead development and transfer of analytical and bioanalytical methods supporting large molecule drugs from early development to commercialization.

The role requires strong chromatographic expertise, QA/GxP experience, and collaboration with cross-functional teams and CROs/CMOs to ensure timely project delivery and regulatory readiness.

Qualifications

• Ph.D. (8+ years) or M.S. (10+ years) in biochemistry, immunoanalytical/analytical chemistry, or related field.
• 6+ years of pharmaceutical industry experience in large molecule analytical development and regulatory submissions.

Responsibilities

• Design, develop, validate, and transfer analytical methods for large and small molecules.
• Lead investigations and troubleshoot issues across development stages.
• Interpret stability and release data to support decision-making for drug products.
• Collaborate with cross-functional teams and CROs/CMOs on CMC projects.
• Prepare CMC sections of INDs/NDAs and regulatory responses.

Skills

HPLC

UPLC

LC-MS

qPCR

Bioassay

GxP

Education

Ph.D. in biochemistry/analytical chemistry

M.S. in biochemistry/analytical chemistry

Tools

ELISA

ddPCR

Job description

HonorVet Technologies is seeking a Sr. Scientist II, Biologics in California to lead development and transfer of analytical and bioanalytical methods supporting large molecule drugs from early development to commercialization.

The role requires strong chromatographic expertise, QA/GxP experience, and collaboration with cross-functional teams and CROs/CMOs to ensure timely project delivery and regulatory readiness.