Principal Scientist

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

Job summary

Trident Consulting is seeking a Senior Analytical Development Scientist / Analytical Lead in the Irvine/Aliso Viejo area. The role leads analytical method development, validation, and transfer for large molecules, collaborating with CROs/CDMOs and cross‑functional teams to support regulatory submissions.

The candidate will manage stability studies, interpret analytical data, mentor staff, and drive multiple projects to IND/NDA readiness, in a fast‑paced biotech environment.

Qualifications

• Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry/Analytical Chemistry.
• 6+ years of pharma industry experience in large‑molecule analytics and regulatory submissions.
• Hands‑on method development, validation, transfer, and troubleshooting.
• Knowledge of GxP, ICH, FDA regulations and stability studies.

Responsibilities

• Develop, validate, and transfer analytical methods for large molecules, proteins, and peptides.
• Perform hands‑on laboratory experiments and operate analytical instruments.
• Develop and troubleshoot biological potency and cell‑based assays.
• Manage stability studies, trend analysis, and analytical data interpretation.
• Collaborate with CROs/CDMOs and serve as the analytical lead on CMC project teams.
• Prepare technical reports and support IND/NDA regulatory submissions.
• Mentor scientists and manage multiple projects.

Skills

Large‑molecule analytics method dev

Hands‑on troubleshooting

CRO/CDMO collaboration

Education

Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry/Analytical Chemistry

Tools

HPLC

UPLC

SEC-HPLC

IEX-HPLC

LC-MS

CE

cIEF

ELISA

MSD

ddPCR

qPCR

Octet

Biacore

Job description

Trident Consulting is seeking a "Senior Analytical Development Scientist / Analytical Lead" for one of our client in "Aliso Viejo, CA" A global leader in business and technology services.

Job Title: Senior Analytical Development Scientist / Analytical Lead

Employment Type: Direct Hire

Salary: $118,000–$148,000 annually + potential bonus and stock

Glaukos is seeking an experienced Analytical Development Scientist to lead hands‑on analytical method development, validation, and transfer for large‑molecule therapeutics. The role requires strong laboratory expertise, independent troubleshooting, biological potency and cell‑based assay experience, and collaboration with CROs/CDMOs and cross‑functional teams.

Key Responsibilities

• Develop, validate, and transfer analytical methods for large molecules, proteins, and peptides.
• Perform hands‑on laboratory experiments and operate analytical instruments.
• Develop and troubleshoot biological potency and cell‑based assays.
• Manage stability studies, trend analysis, and analytical data interpretation.
• Collaborate with CROs/CDMOs and serve as the analytical lead on CMC project teams.
• Prepare technical reports and support IND/NDA regulatory submissions.
• Mentor scientists and manage multiple projects.

Required Qualifications

• Education: Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry, Analytical Chemistry, or a related field.
• At least 6 years of pharmaceutical industry experience in large‑molecule analytical development, drug product analysis, and regulatory submissions.
• Hands‑on experience in analytical method development, validation, transfer, and troubleshooting.
• Strong knowledge of chromatography and large‑molecule characterization.
• Experience collaborating with pharmaceutical CROs/CDMOs.
• Knowledge of GxP, ICH, FDA regulations, and stability studies.

Key Technical Skills

HPLC, UPLC, SEC-HPLC, IEX-HPLC, LC-MS, CE, cIEF, ELISA, MSD, ddPCR, qPCR, Octet, Biacore, biological potency assays, and cell‑based assays.

Top 3 Must-Haves

• Large‑molecule analytical method development.
• Hands‑on laboratory experience with strong troubleshooting skills.
• CRO/CDMO collaboration and effective cross‑functional teamwork.