Lead Scientist

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" for one of our clients in "Aliso Viejo, CA (Onsite)" A global leader in business and technology services.

Please find additional details about the role below:

Title: Lead Scientist-Analytical Development

Type: Direct Hire/Full Time

Salary Range: $118K PA to $148K PA with Benefits

Position Overview

Seeking an experienced, hands-on Analytical Development Scientist/Lead to support large molecule drug development from early clinical studies through commercialization. This role will lead analytical method development, validation, transfer, stability studies, troubleshooting, and analytical activities with internal teams and CROs/CDMOs.

Key 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.

Required 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.

About Trident Consulting

Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we've partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.