Director, Formulation Development

We need to output HTML fragment with sections: About the role (already present), Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. We must not include Job ID etc. Remove boilerplate like EEO, application instructions, etc. We need to parse the posting. First part: "About The Role" paragraph: we can put under

About the role

with

containing that paragraph. Then "Let’s talk about some of the key responsibilities of the role:" then a list of responsibilities. We'll put under

Responsibilities

with

• each bullet. We need to extract bullet points from the long paragraph. The responsibilities are described in sentences after that heading. We need to break them into list items. The text includes many responsibilities separated by periods. We'll need to parse manually. Let's extract responsibilities: - 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. Now "Factors for Success:" includes qualifications, requirements, skills. We need to separate into sections: Requirements, Qualifications, Skills. The posting lumps many items. We need to decide what goes where. We have: 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. Then "A Few Other Details Worth Mentioning:" includes location, hybrid work, remote option, culture, reports to VP, travel up to 20%, benefits description, pay range, benefits details. We need to extract Benefits, Pay, Schedule. Benefits: health, dental and vision insurance, generous paid time off (vacation, holidays, personal days). Also mention onsite gym, pool, snacks, drinks, occasional catered meals. Hybrid work environment, remote work option. Also mention culture etc but those are not benefits. We'll include benefits as list. Pay: expected base pay range $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits. Also mention base pay range reflects target range, individual pay determined by factors. Schedule: hybrid work environment, remote work option, some travel up to 20%. Could be schedule? Not exactly schedule but we can put under Schedule if we have info: hybrid work, remote option, travel up to 20%. Might be considered schedule. We'll include. Now we need sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what goes into Requirements vs Qualifications vs Skills. Typically Requirements: education, years experience, certifications. Qualifications: expertise, knowledge, proven experience. Skills: vendor management, communication, leadership competencies. We'll split. Let's assign: Requirements: - B.S./M.S./Ph.D. in relevant Engineering, Pharmaceutical Sciences, or other related Science field. - Formal project management and/or Lean Six Sigma certifications preferred. - Minimum 15 years pharmaceutical work experience, preferably in development and manufacturing environment, with hands-on or technical training in formulation, drug product development, or process engineering. - At least 5 years people management experience; experience in growing virtual or externally networked company preferred. Qualifications: - Demonstrated expertise in oral formulation and drug-product process development (tablets, capsules; other oral dosage forms and enabling formulation approaches valued). - Strong knowledge of oral drug-product manufacturing (blending, granulation, compression, encapsulation, coating, packaging, process scale-up, technology transfer, clinical manufacturing). - Proven experience directing outsourced formulation development, testing, process development, and manufacturing through CROs and CMOs (governance of quality, cost, timelines, technical deliverables). - Experience leading oral product development programs from preclinical 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, ICH guidance; 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. Skills: - Strong vendor-management, project-planning, budget-management, negotiation skills; track record holding external partners accountable for quality, cost, schedule. - Excellent written and verbal communication skills; ability to influence, align, make decisions across scientific, quality, regulatory, supply, business stakeholders. - Pragmatic, hands-on leadership style suited to growing organization; ability to move between functional strategy, people leadership, technical problem-solving, execution. - Decision Making: demonstrates strong decision-making via structured analysis, balancing priorities, long-term impacts, stakeholder engagement, driving solutions aligned with goals. - Collaboration and Team Building: promotes collaboration aligning diverse teams around shared goals, fostering healthy debate, building strong networks. - Outcome Driven: demonstrates strong outcomes focus aligning teams around shared priorities, proactively addressing risks and dependencies, driving cross-functional accountability. - Empowering Others: fosters empowerment aligning authority with accountability, developing leaders’ decision-making capability, creating systems supporting performance and growth. - Emotional Intelligence: fosters trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, adapting leadership style to support others while maintaining composure under pressure. Now Benefits: list items: - Onsite gym, pool, snacks, drinks, occasional catered meals. - Hybrid work environment; remote work option. - Health, dental, and vision insurance. - Generous paid time off (vacation, holidays, personal days). - Bonus, stock equity (mentioned under pay but could also be benefit). We'll keep under Pay. Pay: base pay range $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits. Also note individual pay determined by factors. Schedule: hybrid work environment, remote work option, some travel up to 20%. We must not include sections with filler like "commensurate with experience". We have real content. Now produce HTML fragment with headings

  and appropriate

  or

  • . Ensure we don't repeat job title. We'll output:

    About the role

    ...

    Then responsibilities list. Then requirements list. Then qualifications list. Then skills list. Then benefits list. Then pay

    . Then schedule

    . Make sure to not include any extra text. Let's craft the About the role paragraph: combine the first paragraph: "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,