Associate Director, Formulations Development (Biotech)

Location: Remote; travel required 10–20%.

Salary: $170,000–$200,000 per year.

Company

hirify.global is a clinical-stage biopharmaceutical company developing oncology therapies through its proprietary Deep Cyclic Inhibition platform.

What you will do

• Oversee drug product development from candidate nomination through clinical development, including pre-formulation, formulation design, scale-up, technology transfer, and manufacturing.
• Conduct API form characterization, formulation screening, and excipient selection studies for solid oral dosage products.
• Define phase-appropriate formulation strategies that balance clinical requirements, manufacturability, regulatory expectations, and commercial considerations.
• Direct process development, technology transfer, and manufacturing campaigns at external CDMOs, including review and approval of protocols, batch records, and campaign reports.
• Establish critical quality attributes and critical process parameters, review investigations and batch disposition records, and support quality drug product delivery for clinical trials.
• Author or review development reports, risk assessments, and CMC sections for IND, IMPD, NDA, and MAA submissions, and respond to regulatory questions.

Requirements

• PhD with 8+ years of industry experience, or MS/BS with 12+ years, in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry, or a related discipline.
• Experience developing formulations for poorly soluble BCS Class II/IV compounds and understanding of solid oral dosage formulation development.
• Experience with drug product technology transfer, manufacturing, and management of CDMOs for research, development, and manufacturing campaigns.
• Understanding of FDA, EMA, and ICH guidance, cGMP requirements, and practical regulatory development strategies.
• Strong technical writing experience, including regulatory submissions and responses to regulatory agencies.
• Ability to work independently, make strategic decisions, and collaborate across cross-functional development teams.

Nice to have

• Experience with granulation, extrusion, spray drying, tableting, coating, and other pharmaceutical manufacturing technologies.
• Experience applying QbD, QTPP, CQA, CMA, CPP, FMEA, and other risk assessment tools.
• Expertise in pediatric formulation development and analytical techniques such as HPLC, LC-MS, XRPD, DSC, dissolution, and KF.
• Experience with IND/IMPD and NDA/MAA submissions and quality investigations.

Culture & Benefits

• Remote work with 10–20% travel for manufacturing and development activities.
• Collaborative, mission-driven environment focused on oncology drug development.
• Commitment to scientific rigor, integrity, ethics, and continuous quality improvement.
• Cross-functional collaboration across CMC and the wider development organization.