Director - Formulation Development

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, 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 health-authority questions, as applicable to the portfolio.
• Own functional resource planning, vendor forecasts, project budgets, and operating plans; proactively identify capability, capacity, schedule, and supply risks and recommend mitigation strategies.
• Support technical due diligence, asset evaluations, intellectual-property assessments, and portfolio planning by evaluating oral product feasibility, development requirements, timelines, costs, and risks.
• Perform other related duties as required or assigned.

Factors for Success:

• B.S./M.S./Ph.D. in a relevant Engineering, Pharmaceutical Sciences, or other related Science field. Formal project management and/or Lean Six Sigma certifications preferred.
• A minimum of fifteen (15) years of pharmaceutical work experience, preferably in a pharmaceutical development and manufacturing environment, with hands-on or technical training in formulation, drug product development, or process engineering, depending on level of education.
• At least 5 years of people management experience; experience within a growing virtual or externally networked company environment preferred.
• Demonstrated expertise in oral formulation and drug-product process development, preferably including tablets and capsules; experience with other oral dosage forms and enabling formulation approaches is highly valued.
• Strong knowledge of oral drug-product manufacturing, including blending, granulation, compression, encapsulation, coating, packaging, process scale-up, technology transfer, and clinical manufacturing.
• Proven experience directing outsourced formulation development, testing, process development, and manufacturing through CROs and CMOs, including governance of quality, cost, timelines, and technical deliverables.
• Experience leading oral product development programs from preclinical development through Phase 3 or registration-enabling activities, with sound judgment regarding phase-appropriate development and control strategies.
• Strong working knowledge of cGMP requirements and relevant FDA, EMA, and ICH guidance, together with experience contributing to global regulatory CMC submissions and health-authority interactions.
• Demonstrated ability to interpret complex formulation, analytical, manufacturing, stability, and process data and translate findings into clear development decisions and risk-based plans.
• Strong vendor-management, project-planning, budget-management, and negotiation skills, with a track record of holding external partners accountable for quality, cost, and schedule.
• Excellent written and verbal communication skills and the ability to influence, align, and make decisions across scientific, quality, regulatory, supply, and business stakeholders.
• A pragmatic, hands-on leadership style suited to a growing organization, with the ability to move between functional strategy, people leadership, technical problem-solving, and execution.
• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
• Empowering Others - Fosters empowerment by aligning authority 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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