Bioanalytics Strategy Lead, Drug Development

Latigo Bio; San Francisco (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Latigo Biotherapeutics, Inc. in Thousand Oaks, CA or San Francisco, CA invites an experienced Associate Director, Bioanalytics to lead bioanalytical strategies across discovery, nonclinical, and clinical programs.

You will oversee method development, validation, and CRO partnerships to deliver high-quality data for regulatory submissions. The ideal candidate brings deep LC-MS/MS expertise, ligand binding assay experience, and a proven track record in cross-functional leadership and regulatory

Qualifications

• Deep expertise in ligand binding assays and LC-MS/MS
• Experience with bioanalytical method validation
• Regulatory submissions experience (INDs, CTAs, NDAs)

Responsibilities

• Develop and execute bioanalytical strategies across discovery to clinical development.
• Lead cross-functional bioanalytical project teams.
• Manage CROs and external labs for method development, transfer and validation.
• Review study protocols, validation reports and data packages for quality and timeliness.
• Collaborate with QA on inspections, deviations, and CAPAs.

Skills

Bioanalytical leadership

Regulatory liaison

LC-MS/MS expertise

CRO management

Education

PhD in Analytical Chemistry

MS in a related field (12+ years)

MS in a related field (15+ years)

Tools

GLP/GCP understanding

Job description

Latigo Biotherapeutics, Inc. in Thousand Oaks, CA or San Francisco, CA invites an experienced Associate Director, Bioanalytics to lead bioanalytical strategies across discovery, nonclinical, and clinical programs.

You will oversee method development, validation, and CRO partnerships to deliver high-quality data for regulatory submissions. The ideal candidate brings deep LC-MS/MS expertise, ligand binding assay experience, and a proven track record in cross-functional leadership and regulatory