Lead Bioassay Scientist - Large Molecule & CMC Expert

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

Job summary

Trident Consulting is seeking a Senior Bioassay Scientist in Aliso Viejo, CA to develop, validate, and transfer analytical and bioassay methods for large molecule drug development. You'll lead data generation, oversee stability studies, and collaborate across CMC teams.

The role requires expertise in chromatographic and bioanalytical techniques, experience with regulated environments, and ability to author CMC sections for regulatory submissions. Strong communication and leadership are essential.

Qualifications

• Ph.D. (8+ years) or M.S. (10+ years) in biochemistry, immunoanalytical/analytical chemistry, or a related field.
• 6+ years of pharmaceutical industry experience in large molecule analytical development and regulatory submissions.
• Experience leading investigations and cross-functional collaboration.
• Experience with CROs/CMOs interactions and regulatory inquiries.
• Strong communication and regulatory documentation skills.

Responsibilities

• Lead analytical development for large molecules from discovery through commercialization.
• Oversee stability studies and data trending across programs.
• Author CMC sections of INDs/NDAs and respond to regulatory questions.
• Mentor scientists and coordinate with CROs/CMOs to ensure timely delivery.
• Maintain expertise in cutting-edge analytical technologies and troubleshooting.

Skills

Chromatography expertise

Analytical method development

Cross-functional collaboration

Regulatory compliance understanding

Education

Ph.D. in biochemistry/analytical chemistry or related

M.S. in biochemistry/analytical chemistry or related

Tools

HPLC

UPLC

LC-MS

cIEF

ELISA

qPCR

Job description

Trident Consulting is seeking a Senior Bioassay Scientist in Aliso Viejo, CA to develop, validate, and transfer analytical and bioassay methods for large molecule drug development. You'll lead data generation, oversee stability studies, and collaborate across CMC teams.

The role requires expertise in chromatographic and bioanalytical techniques, experience with regulated environments, and ability to author CMC sections for regulatory submissions. Strong communication and leadership are essential.