Director, Oral Drug Product Development (Biotech)

Location: Cambridge, Massachusetts, United States

Salary: $188,000–$259,000 per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines with the resources and stability of an established business.

What you will do

• Lead formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing for small-molecule oral dosage forms.
• Develop formulation approaches for poorly soluble, poorly permeable, unstable, and complex compounds, including orally delivered peptides.
• Represent drug product development on cross-functional CMC and asset teams spanning regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partners.
• Assess developability, biopharmaceutical performance, technical risk, manufacturability, and investment priorities to support portfolio decisions.
• Oversee manufacturing strategies, clinical manufacturing readiness, technology transfer, regulatory submission sections, and technical documentation.
• Mentor scientists and engineers while implementing new formulation technologies, predictive tools, digital workflows, and development best practices.

Requirements

• PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline.
• At least 12 years of experience in oral drug product development.
• Track record leading formulation and process development for oral solid dosage forms from early development through clinical manufacturing or late-stage development.
• Experience with scale-up, technology transfer, clinical manufacturing, external manufacturing organizations, and CMC development.
• Ability to lead across functions, influence program strategy, manage technical risk, and communicate with diverse stakeholders.
• Experience mentoring, developing, or leading scientists and engineers.

Nice to have

• Expertise in amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.
• Experience with late-stage development, commercial readiness, process characterization, process validation, or oral solid dose manufacturing operations.
• Experience supporting an NDA, MAA, or commercial product and interacting with regulatory agencies.
• Experience implementing new technologies, digital tools, knowledge platforms, or best practices across multiple programs.
• Experience managing external CDMO or CMO relationships and technology transfer activities.

Culture & Benefits

• Medical, dental, vision, and life insurance.
• Fitness and wellness programs, including fitness reimbursement.
• Paid vacation, company holidays, sick time, end-of-year shutdown, and parental leave.
• 401(k) with company matching, employee stock purchase plan, and short- and long-term incentives.
• Tuition reimbursement of up to $10,000 per calendar year and Employee Resource Group participation.
• Inclusive environment focused on collaboration, learning, growth, and scientific excellence.