Associate Director, Drug Product & Process Development (Small Molecules)

Location: Remote within the United States

Salary: $169,222–$253,000 annually, plus incentive opportunity

Company

hirify.global is a pharmaceutical company developing and commercializing medicines, with a focus on patient and customer needs.

What you will do

• Lead late-stage small-molecule drug product development from Phase 2/3 through commercial launch, including formulation optimization, robustness studies, and validation readiness.
• Oversee manufacturing process scale-up, technology transfer, process performance qualification, and commercial manufacturing support.
• Develop Quality by Design strategies, including critical material attributes, critical process parameters, and control strategies.
• Author and review technical development plans, process descriptions, development reports, and validation summaries.
• Lead CMC drug product content for NDA and/or MAA filings and support FDA, EMA, and other health authority interactions.
• Drive post-approval lifecycle management, process improvements, alternate sourcing, and cross-functional collaboration with Regulatory, Quality, Manufacturing, Supply Chain, Clinical, and Commercial teams.

Requirements

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or a related discipline with 5+ years of relevant industry experience; or MS with 8+ years or BS with 10+ years of progressive experience.
• Demonstrated late-stage drug product development experience from Phase 3 through commercialization.
• Direct experience authoring and supporting NDA or equivalent CMC submissions and interacting with regulatory agencies.
• Expertise in drug product manufacturing processes, scale-up, technology transfer, and validation.
• Strong knowledge of CMC regulatory requirements, global regulatory frameworks, and ICH Q8–Q12 guidelines.
• Hands-on experience with lifecycle management and post-approval changes, plus strong technical writing and cross-functional collaboration skills.

Nice to have

• Experience working with external manufacturing partners and CDMOs.
• Experience with aseptic, solid oral, or other relevant dosage forms.
• Experience supporting commercial manufacturing and supply operations.
• Prior people leadership or matrix leadership experience.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Emphasis on accountability, strategic problem solving, impactful communication, respectful collaboration, and professional development.