Associate Director, Analytical Development (Small Molecules)

Location: Princeton, New Jersey, United States

Salary: $169,222–$253,000 per year, plus incentive opportunity.

Company

hirify.global develops and commercializes pharmaceutical products and supports drug development through regulatory approval and commercialization.

What you will do

• Lead analytical development strategy and governance for a portfolio of small molecule programs from early development through NDA submission, approval, and commercialization.
• Own analytical narratives and positioning for NDAs, covering drug substance, drug product, impurities, stability, and control strategies.
• Support FDA and global Health Authority interactions, including NDA reviews, Type C and pre-NDA meetings, information requests, and pre-approval inspections.
• Manage analytical risk, comparability, method lifecycle evolution, validation timing, specifications, and post-approval change strategies.
• Establish analytical governance and resolve high-impact issues with CDMOs and CROs.
• Partner with Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain while building analytical capabilities and mentoring managers.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline, or an M.S. with extensive directly relevant industry experience.
• 12–15+ years of pharmaceutical or biotech industry experience in small molecule analytical development.
• Experience leading programs from early development through NDA filing and approval, including NDA analytical strategy and Health Authority engagement.
• Experience leading analytical functions in outsourced or CDMO-based development models.
• Deep expertise in stability-indicating methods, including HPLC/UPLC, GC, and dissolution; impurity control; and solid-state characterization using XRPD, DSC, and TGA.
• Strong knowledge of ICH Q1, Q2, Q3A/B, Q3C, Q6A, and FDA expectations for NDAs, with strong regulatory writing, presentation, and matrix leadership skills.

Culture & Benefits

• Full-time position with a focus on accountability, strategic thinking, patient and customer centricity, impactful communication, respectful collaboration, and professional development.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
• Tuition reimbursement, student loan assistance, and a generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.