Associate Director, Small Molecule Analytical Development

Location: On Campus, Cambridge, MA, United States

Base salary: $159,000–$219,000 per year

Company

hirify.global is a biotechnology company developing life-changing medicines through scientific rigor, collaboration, and continuous improvement.

What you will do

• Lead analytical development for small molecule drug substance and drug product programs from early development through registration and commercialization.
• Develop analytical methods and control strategies covering identity, assay, impurities, degradation products, residual solvents, elemental impurities, solid-state attributes, dissolution, and other critical quality attributes.
• Guide impurity identification, forced degradation, stability strategy, comparability assessments, and specification justification.
• Represent Analytical Development on cross-functional CMC teams and contribute to project strategy, risk assessment, planning, and decisions.
• Author and review analytical content for INDs, CTAs, NDAs, MAAs, validation reports, transfer reports, and responses to health authorities.
• Oversee CRO, CDMO, and manufacturing analytical activities while managing, mentoring, and developing scientists.

Requirements

• Ph.D. with at least 6 years, M.S. with at least 8 years, or B.S. with at least 10 years of relevant pharmaceutical or biotechnology development experience.
• Experience in small molecule analytical development, including chromatographic or spectroscopic method development, validation, transfer, impurity profiling, stability, and specification setting.
• Working knowledge of ICH guidance, GMP principles, regulatory expectations, and quality standards for analytical development and CMC submissions.
• Experience leading analytical workstreams, project teams, or cross-functional CMC activities in a matrixed environment.
• Experience managing, mentoring, or developing scientific staff.
• Strong written and verbal communication skills for technical and non-technical audiences.

Nice to have

• Experience supporting programs through late-stage registration, launch, or post-approval lifecycle management.
• Experience with mass spectrometry, NMR, solid-state characterization, dissolution, degradation pathways, or drug product analytical development.
• Experience working with CROs, CDMOs, QC laboratories, and regulatory submissions.
• Experience with digital analytical workflows, automation, electronic laboratory systems, modeling, data visualization, or emerging analytical technologies.
• Scientific publications, presentations, professional society engagement, or consortia participation.

Culture & Benefits

• Full-time employment with medical, dental, vision, life, disability, and wellness benefits.
• Short- and long-term incentives, including cash bonuses and equity opportunities.
• Paid vacation, company holidays, sick time, parental leave, and end-of-year shutdown time.
• 401(k) program with company matching and an employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Inclusive environment focused on collaboration, learning, growth, and continuous improvement.