Director, Formulation Development

Position Summary

The Director, Formulation Scientist drives formulation innovation, technical strategy, and commercial readiness across expanding 503A and 503B portfolios, directly influencing product quality, regulatory compliance, operational scalability, and revenue growth. This leader owns formulation development from concept through transfer, overseeing scientific rigor, cross-functional execution, risk mitigation, and accelerated delivery within a highly regulated environment. The role leverages AI-enabled tools to improve experimentation speed, predictive modeling, documentation quality, knowledge management, and data-driven decision-making.

Responsibilities

Formulation Strategy

• Lead formulation strategy across sterile and nonsterile pipelines.
• Use AI-enabled analytics to improve formulation predictability and technical decisions.
• Establish formulation roadmaps supporting pipeline expansion and differentiated product development.
• Integrate AI-assisted modeling, literature mining, and digital experimentation tools.
• Direct scientific governance frameworks ensuring compliant development practices.
• Utilize AI-driven trend analysis, data visualization, and knowledge management systems.

Technical Execution

• Oversee formulation development from feasibility through commercial readiness.
• Apply AI-supported analytics to optimize formulations and improve batch consistency.
• Lead formulation optimization initiatives focused on scalability and manufacturability.
• Utilize AI-enabled process intelligence and predictive monitoring.
• Resolve scientific, operational, and quality challenges impacting commercialization.

Cross Functional Leadership

• Build partnerships across quality, manufacturing, regulatory, analytical, and commercial teams.
• Leverage AI-enhanced collaboration and reporting tools.
• Recruit, develop, and retain scientific talent.
• Deliver data-driven updates and strategic recommendations.

Quality and Compliance

• Ensure compliance with regulatory requirements and internal quality systems.
• Utilize AI-driven compliance monitoring and audit tools.
• Lead scientific and operational risk management activities.
• Establish documentation practices ensuring traceability and inspection readiness.

Operational Advancement

• Drive scalable formulation and process strategies supporting product launches.
• Champion advanced technologies, digital platforms, and AI-enabled capabilities.
• Integrate automation, predictive analytics, and connected data systems.
• Lead continuous improvement initiatives enhancing scientific execution and operational discipline.

Knowledge and Skills

• Deep expertise in pharmaceutical formulation development, technology transfer, process optimization, and scalable manufacturing operations.
• Experience leveraging AI-enabled analytics, predictive modeling, and digital tools.
• Strong leadership, stakeholder management, and executive communication skills.
• Analytical thinking and continuous improvement mindset.

Experience and Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or related scientific discipline required.
• Minimum ten years of progressive formulation development experience.
• Experience leading formulation strategy, technology transfer, process optimization, and commercialization.
• Experience building technical teams and driving scalability.
• Experience utilizing AI-enabled technologies, advanced analytics, or digital scientific platforms preferred.

Key Competencies

• Customer Focus
• Strategic AI
• Optimizes Work Processes
• Collaborates
• Resourcefulness
• Manages Complexity
• Ensures Accountability
• Situational Adaptability
• Communicates Effectively

Values

• People: Empowering people defines who we are.
• Quality: Excellence in every product, every time.
• Service: Serving others is our highest purpose.
• Innovation: Advancing care through technology and discovery.

Employee Benefits, Health and Wellness

• Medical, dental, and vision coverage
• Paid time off
• 401(k) matching
• Wellness perks
• IV therapy
• Compounded medications

Physical Requirements

• Frequent computer and office equipment use
• Standing, walking, reaching, balancing, stooping, kneeling, crouching, and crawling as required