Director, Formulation Development

Reporting to the VP, Manufacturing Operations & Supply Chain, the Director, Formulation Development will lead oral drug product development across the Tarsus portfolio. This role is accountable for the scientific strategy and execution of oral formulation and process development through external contract research organizations (CROs) and contract manufacturing organizations (CMOs), as well as for leadership and development of internal personnel. The Director will advance oral products from preclinical development through Phase 3, registration readiness, and technology transfer, ensuring that formulations, manufacturing processes, control strategies, packaging approaches, and clinical supply plans are scientifically sound, phase‑appropriate, scalable, and aligned with program objectives.

• Lead the Formulation Development function and provide scientific, technical, and people leadership for employees and contingent staff responsible for externally executed development programs.
• Establish formulation development strategies for tablets, capsules, and other oral dosage forms, using a QbD approach, translating target product profiles into phase‑appropriate formulation, process, packaging, and manufacturing plans.
• Direct external preformulation, formulation, and process‑development work through CROs and other development partners, including experimental design, prioritization, execution, data interpretation, documentation, and recommendations for program decisions.
• Manage, coach, and develop product development personnel; set clear objectives, allocate resources across programs, build technical and vendor‑management capabilities, and foster a culture of scientific rigor, accountability, and collaboration.
• Establish an effective operating model for externally executed development, including clear decision rights, technical governance, documentation and data‑integrity expectations, issue escalation, and coordination with Analytical Development, Quality, Regulatory CMC, and Clinical Supply.
• Select and manage external CROs and development partners; define scopes of work, technical deliverables, timelines, budgets, data‑quality expectations, and governance mechanisms, and ensure external work is integrated into the product‑development strategy.
• Provide technical leadership for CMO selection, technology transfer, scale‑up, engineering and GMP clinical manufacturing, registration‑enabling activities, and transfer to additional manufacturing sites as required.
• Oversee CMO execution and documentation, including development protocols and reports, master and executed batch records, deviations, investigations, change controls, CAPAs, process descriptions, and manufacturing readiness assessments.
• Apply oral product development expertise to formulation design and optimization, solubility and bioavailability enhancement, excipient selection, blending, granulation, compression, encapsulation, coating, dissolution, packaging, process scale‑up, and manufacturing risk mitigation, as applicable to the portfolio.
• Partner with Analytical Development to establish phase‑appropriate methods, specifications, stability and dissolution strategies, comparability plans, and integrated drug‑product control strategies.
• Serve as the drug‑product technical lead and Pharmaceutical Sciences representative in cross‑functional program teams, working closely with Regulatory CMC, Quality, Clinical Supply, Supply Chain, Project Management, and other functions to deliver program milestones and resolve technical or operational risks.
• Author and review CMC sections of regulatory submissions and responses, including INDs, IMPDs, NDAs/BLAs, MAAs, briefing packages, and…