Lead Scientist, Analytical Development - Large Molecules

Trident Consulting; Irvine (CA); On-site; USD 118,000 - 148,000; Full time

Job summary

Trident Consulting is seeking a Lead Scientist-Analytical Development in Aliso Viejo, CA to drive analytical method development for large molecule drug candidates. Onsite role directing method validation, transfers, stability studies, and regulatory-ready CMC documentation, partnering with cross-functional teams and CROs/CDMOs.

The ideal candidate has a Ph.D. with 8+ years (or an MS with 10+ years) in Biochemistry/Analytical Chemistry and hands-on expertise with HPLC/UPLC, LC-MS, and

Qualifications

• Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry, Analytical Chemistry, Immunoanalytical Chemistry, or related field.
• 6+ years of pharmaceutical industry experience in large molecule analytical development.
• Strong hands-on experience with analytical method development for large molecules.
• Experience with HPLC, UPLC, IEX, SEC, LC-MS, CE, cIEF, ELISA, qPCR/ddPCR, Octet, Biacore, or similar technologies.
• Experience with method validation, method transfer, stability studies, and troubleshooting.
• Experience working with CROs and CDMOs.
• Strong communication, collaboration, project leadership, and problem-solving skills.
• Experience working in GxP/ICH/FDA-regulated environments.

Responsibilities

• Develop, validate, transfer, and troubleshoot analytical and bioanalytical methods for large molecules.
• Perform hands-on laboratory experiments and independently operate analytical instruments.
• Lead analytical activities and serve as the analytical lead on CMC project teams.
• Manage stability studies, data trending, and interpretation of release and stability results.
• Collaborate with cross-functional teams, CROs, and CDMOs to deliver projects on time and with high quality.
• Support QC with method validation, method transfer, specifications, and robust analytical methods.
• Prepare technical reports, protocols, and CMC documentation for regulatory submissions.
• Provide technical guidance and training to scientists.

Skills

Analytical development leadership

Large molecule analytics

Cross-functional collaboration

Troubleshooting

Project management

Regulatory knowledge

Communication skills

Education

Ph.D. in Biochemistry/Analytical Chemistry

M.S. in Biochemistry/Analytical Chemistry

Tools

HPLC

UPLC

LC-MS

IEX

SEC

CE

cIEF

ELISA

qPCR/ddPCR

Biacore

Octet

Job description

Trident Consulting is seeking a Lead Scientist-Analytical Development in Aliso Viejo, CA to drive analytical method development for large molecule drug candidates. Onsite role directing method validation, transfers, stability studies, and regulatory-ready CMC documentation, partnering with cross-functional teams and CROs/CDMOs.

The ideal candidate has a Ph.D. with 8+ years (or an MS with 10+ years) in Biochemistry/Analytical Chemistry and hands-on expertise with HPLC/UPLC, LC-MS, and