Associate Director, Analytical Development (Biologics)

Location: South San Francisco, California, United States

Salary: $172,000–$215,000 annually, plus bonus and equity

Company

hirify.global is an innovative biotech startup using generative AI and foundation models for biology and disease to support drug discovery, protein and antibody therapeutics, target elucidation, and patient stratification.

What you will do

• Lead analytical method development, qualification, validation, and transfer across the biologics product lifecycle.
• Oversee analytical testing for reference standards, starting materials, intermediates, drug substance, drug product, release, and stability programs.
• Manage contract laboratories, CMOs, CDMOs, and external consultants while ensuring technical alignment, scientific rigor, and quality compliance.
• Develop phase-appropriate analytical and CMC strategies aligned with regulatory expectations.
• Author and technically review CMC sections for IND, IMPD, BLA, MAA, and related regulatory submissions.
• Support investigations of out-of-specification results, deviations, non-conformances, root causes, and CAPA development while partnering with Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs.

Requirements

• PhD in analytical chemistry or a related discipline with more than 8 years of industry experience, or BS/MS degree with more than 15 years of industry experience.
• Experience in analytical development, method validation, method transfer, and molecular stability management in a regulated biopharmaceutical or pharmaceutical environment.
• Strong knowledge of biologics CMC development, complex modalities such as multispecifics, cGMP expectations, quality systems, and regulatory submissions.
• Experience supporting protein therapeutics or other complex biologics modalities from early development through clinical-stage execution.
• Hands-on experience with HPLC, UHPLC, LC-MS, SEC, RP, and IEX chromatography.
• Experience authoring or reviewing CMC content for IND, IMPD, BLA, MAA, or related submissions.

Nice to have

• Experience with CE-SDS, icIEF, binding and potency assays, impurity and residual testing, including HCP, DNA, and residual Protein A.
• Experience with drug product assays, stability testing, and formulation-related analytical methods.

Culture & Benefits

• Open, flexible, and friendly work environment.
• Competitive compensation and benefits package with base salary, bonus, and equity.
• Opportunity to develop a long-term career in an AI-focused biotech startup.
• Focus on collaboration, scientific rigor, continuous improvement, and a strong quality culture.
• Commitment to diversity and inclusion as an equal-opportunity employer.