Director, Bioanalytics

Scorpion Therapeutics; San Francisco (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Vir Biotechnology seeks a Director of Bioanalytical Science to provide scientific, technical, and regulatory leadership for developing and validating assays supporting infectious disease and cancer programs. Responsibilities include leading immunoassay and bioanalytical method development for PK/PD/ADA, mentoring teams, overseeing transfers to CROs, and preparing regulatory documentation.

Location: San Francisco HQ, onsite at least three days per week, with cross‑functional collaboration as

Qualifications

• MS or PhD in Analytical Chemistry, Biochemistry, or related field with 10+ years bioanalytical biologics development experience.
• Deep expertise in immunoassay development, validation, and GxP compliance.
• Knowledge of GLP/GxP systems and regulatory submissions (e.g., 21 CFR Part 11).
• Preferred: experience with large molecule bioassays, statistical tools, and team leadership.

Responsibilities

• Lead complex immunoassay and bioanalytical method development for PK/PD/ADA assessments.
• Manage and mentor bioanalytical teams.
• Oversee transfer, validation, and troubleshooting of methods at CROs.
• Prepare regulatory documentation and participate in audits.
• Collaborate with research, clinical, and sample management teams to ensure timely sample analysis and data delivery.
• Drive continuous process improvements and system updates.

Skills

Immunoassay development

Bioanalytical method development

Team leadership

Regulatory compliance (GxP)

Regulatory submissions

Education

MS or PhD in Analytical Chemistry/Biochemistry or related field

Job description

Role: Director, Bioanalytical Science at Vir Biotechnology, providing scientific, technical, and regulatory leadership for developing and validating assays supporting infectious disease and cancer programs.

Responsibilities

• lead complex immunoassay and bioanalytical method development for pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody (ADA) assessments;
• manage and mentor bioanalytical teams;
• oversee transfer, validation, and troubleshooting of methods at CROs;
• prepare regulatory documentation and participate in audits;
• collaborate with research, clinical, and sample management teams to ensure timely sample analysis and data delivery;
• drive continuous process improvements and system updates.

Requirements

• MS or Ph.D. in Analytical Chemistry, Biochemistry, or related field with 10+ years or Bachelor's with 15+ years of bioanalytical biologics development experience;
• deep expertise in immunoassay development, validation, and GxP compliance;
• knowledge of GLP/GxP systems and regulatory submissions (e.g., 21 CFR Part 11).

Preferred: experience with large molecule bioassays, statistical tools, and team leadership.

High-value specifics: biologics, immunoassays, PK/PD/ADA testing, GLP/GxP validation, regulatory interactions, infectious diseases, oncology, biologic therapeutics.

Location: San Francisco HQ, at least three days/week onsite, with some cross-functional collaboration.