Director, Formulation Development

The posting, as Tarsus Pharmaceuticals wrote it

About the Role

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.

Let’s talk about some of the key responsibilities of the role:

• 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, granula

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thority with accountability, developing leaders’ decision-making capability, and creating systems that support performance and growth.

• Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure.

A Few Other Details Worth Mentioning

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our VP, Manufacturing Operations & Supply Chain.
• Some travel may be required – up to 30%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot .

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Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.