Director Paediatrics - Formulation and Process Design

AstraZeneca • Durham, NC

32d • Hybrid

About The Position

Are you ready to revolutionize how children access life-changing medicines? Join us as a transformational leader who turns cutting-edge science into breakthrough paediatric treatments—where every strategic decision you make accelerates healing for young patients whilst driving unprecedented commercial success. This isn't just another leadership role; it's your opportunity to pioneer the future of child-centric pharmaceutical innovation and leave an indelible mark on global healthcare!
You will lead the paediatrics formulation and process development function, partnering across development and manufacturing to deliver a complex, global portfolio. From advancing new physical and chemical structures to embedding digital, data science, predictive modeling, sophisticated in vitro methods and AI, you will build the capability and practices that make our pipeline more agile, efficient and right-first-time!
This is a hands-on, globally connected role with clear accountability for strategy, delivery, people, quality and budget. How will you grow a forward-looking, digitally enabled team while delivering today’s milestones and preparing for tomorrow’s challenges?

Requirements

• Proven leadership of pharmaceutical scientists in formulation and process development with responsibility for paediatric portfolios in late-stage development and on-market support.
• Track record in developing drug products to maximise active agent effectiveness.
• Experience managing development teams and manufacturing design teams, or contributing expert knowledge in physical drug design.
• Ability to drive a forward-looking science and technology vision and provide expert technical direction and problem solving.
• Implementation of new methodologies and technologies in area of expertise, including training of staff.
• Experience collecting and coordinating input from multiple functions, including Research and Development and Manufacturing, to maximise drug effectiveness and manufacturing efficiency while reducing cost.
• Responsibility for determining which methodologies and technologies to pursue and allocating resources accordingly.
• Impact at a global level by advising on project design, progress, priorities, resourcing and future strategies; participation in cross-functional and cross-brand networks.
• Experience working across regions and skill groups within and outside own function.
• Up-to-date knowledge of technical advances in pharmaceutical science and ability to communicate developments to raise competence and industry awareness.
• Application of pharmaceutical science expertise to support documents for internal teams and external regulators.
• Demonstrated adherence to SHE, GLP, cGMP and compliance standards for own and team’s work.
• People leadership for a group of approximately 4–8, including coaching for enhanced performance and development.
• Experience leading implementation of strategy and associated change plans; role modelling Lean leadership and new practices to drive agility, efficiency and delivery.
• Ability to develop and implement innovative, digitally oriented approaches employing data science, predictive modelling, advanced in vitro studies and AI, and strategic workforce planning.
• Financial accountability for preparing and managing revenue and capital budgets.
• Ability to operate confidently as part of a global organisation with an integrating outlook to prepare for future challenges and change; ensuring capability development for an emerging and diverse portfolio.
• Experience developing project delivery strategies with Project Managers and solving diverse problems using complex judgement, conceptual thinking and strategic analysis.
• Strong interpersonal skills to influence and shape the image of the group and department; excellent communication to set direction, objectives and motivate and engage staff.

Nice To Haves

• Advanced degree or equivalent experience in pharmaceutical sciences, chemical engineering or related field.
• Expertise in paediatric biopharmaceutics, palatability and acceptability, and age-appropriate dosage form design.
• Demonstrated application of model-informed product development and in silico tools to guide formulation and process decisions.
• Experience transferring technologies to commercial manufacturing and managing lifecycle changes for paediatric products.
• Track record interacting with global health authorities and contributing to paediatric regulatory submissions.
• Certification or leadership in Lean, Six Sigma or similar continuous improvement methodologies.
• Experience building external collaborations with CROs, CMOs, academia and consortia.
• Proven success building inclusive, high-performing, geographically distributed teams.

Responsibilities

• Strategic Leadership: Set and implement the vision for paediatric formulation and process engineering, aligning science and technology roadmaps to late-stage and on-market portfolio needs for maximum patient and business impact.
• Portfolio Delivery: Define delivery strategies with Project Managers; ensure timely, compliant, and cost-effective progression of paediatric projects from development to commercial readiness.
• Science and Technology Innovation: Drive age appropriate formulation and process development in line with strategic intents
• Digital and Data-Enabled Approaches: Implement future-focused, innovative and digitally oriented approaches employing data science and predictive approaches to enhance accuracy, quality and speed
• Leadership: Oversee a team of approximately 4–8 pharmaceutical scientists across multiple regions. Mentor their performance, engagement, and development. Guide strategic workforce planning to prepare for the future portfolio.
• Method and Practice Improvement: Lead local implementation of strategy and change plans; role model Lean leadership to increase flexibility, agility, efficiency and delivery.
• Cross-Functional Integration: Collect and coordinate input from Research and Development and Manufacturing to maximise product effectiveness and manufacturability while reducing cost; participate in cross-functional and cross-brand networks.
• Technical Governance and Compliance: Ensure SHE, GLP and cGMP standards are met for all work; uphold quality and compliance across projects and sites.
• Budget Ownership: Prepare and agree revenue and capital budgets; control expenditure within budget to deliver value.
• Decision Making and Advisory: Advise senior management on project design, progress, priorities, resourcing and future strategies; develop solutions to diverse problems using complex judgement and strategic analysis.
• Communication and Influence: Communicate scientific and technological developments to increase competence and awareness; set clear direction and objectives that motivate and engage staff; shape the image of the group and department.

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director