Associate Director, Analytical Development & QC (Pharma)

Location: Hybrid, requiring 3 days per week in the office in the Boston or New York City metro areas. Applicants in the Research Triangle or San Francisco Bay Area may also be considered. Applicants must reside in these locations or be willing to relocate.

Total compensation: $177,500–$232,000 per year, plus equity, comprehensive benefits, and perks.

Company

hirify.global is a technology- and AI-driven pharmaceutical company developing platforms and programs that accelerate drug development and clinical trials.

What you will do

• Lead the development, optimization, and validation of phase-appropriate analytical methods for small-molecule and biologics drug substances and drug products.
• Manage in-process, release, and stability testing with CDMOs and contract testing laboratories.
• Provide technical oversight for method transfers, comparability assessments, laboratory readiness, and external vendor performance.
• Oversee stability programs, including protocol approval, data review and trending, shelf-life and retest dating, metrics, and stability-related inquiries.
• Manage critical reagents and reference standards, and lead investigations into OOS/OOT results, deviations, CAPAs, and change controls.
• Author and review analytical CMC documents, regulatory submissions, SOPs, and work instructions while collaborating with CMC, QA, and Regulatory teams.

Requirements

• Master’s degree in Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline with 5+ years of relevant experience, or a Bachelor’s degree with 8+ years.
• Extensive hands-on experience developing, optimizing, and validating analytical methods for release and stability testing of small molecules and biologics.
• Experience with biologics methods such as qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, and glycan analysis, as well as small-molecule methods including UHPLC, IC, GC, IR, UV, KF, PSD, and dissolution.
• Experience authoring and reviewing analytical methods, validation documents, specifications, stability documentation, technical reports, and SOPs.
• Strong knowledge of stability study design, data trending, ICH, FDA, EMA, and GMP requirements; working knowledge of Smartsheet and JMP.
• Ability to work in a fast-paced, virtual, outsourced development environment and travel domestically and internationally up to 25%.

Culture & Benefits

• Hybrid work model with a focus on the Boston and New York City metro areas, with consideration for additional US hubs.
• Equity, comprehensive benefits, and generous perks.
• Opportunity to work across a portfolio of small-molecule and biologics development programs.
• Collaborative work with CMC, QA, Regulatory teams, CDMOs, and contract laboratories.