Director, Pharmaceutical Development (Small Molecule)

Location: On site in the Brisbane, California office; primarily office and laboratory work with occasional GMP manufacturing facility access and approximately 25% domestic and international travel.

Salary: $218,000–$260,000 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases through an AI-integrated discovery engine.

What you will do

• Lead QbD-based formulation and process development for small-molecule oral and topical dosage forms from early development through commercial launch.
• Develop enabled formulations, including amorphous solid dispersions, lipid-based delivery systems, and nano-formulations to address solubility and bioavailability challenges.
• Define QTPPs and CQAs, conduct CMA and CPP risk assessments, and establish robust, scalable manufacturing processes.
• Lead laboratory-to-pilot-to-commercial scale-up, technology transfer, process qualification, deviation investigation, and corrective actions.
• Drive late-stage development, clinical supply manufacturing, PPQ, CPV, and CMC contributions to IND, NDA, and MAA submissions.
• Manage CDMO partnerships and coordinate with Analytical Development, Clinical Operations, Regulatory Affairs, Quality, Supply Chain, and Commercial teams.

Requirements

• Ph.D. strongly preferred in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a related discipline.
• At least 12 years of progressive pharmaceutical development experience in biotechnology, pharmaceutical, or CDMO settings.
• Deep experience with small-molecule drug product development, oral and topical dosage forms, enabled formulations, QbD, DoE, design spaces, and control strategies.
• Significant Phase 2b/3 and commercial development experience, including CMC submissions, agency responses, lifecycle management, post-approval changes, and SUPAC guidance.
• Direct CDMO management experience and demonstrated people management, strategic planning, and budget ownership across multiple programs.
• Must be able to gown for cleanroom and GMP environments and travel approximately 25%.

Culture & Benefits

• Collaborative, strongly team-oriented working environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful culture open to diverse points of view.
• Opportunity to provide scientific leadership and mentor scientists, associates, and project team members.