The Principal Research Scientist II / Associate Director provides scientific, technical, and people leadership for the formulation and process development of sterile liquid dosage forms, with an emphasis on eyecare products. The role directs development activities for new chemical entities and life-cycle management programs from early research through clinical supply, technology transfer, regulatory submission, and commercialization. The candidate leads a team of scientists responsible for formulation, process, and associated analytical-method development.

Responsibilities

• Provide scientific and technical leadership for the development of sterile liquid dosage forms and eyecare products, including formulation, associated analytical methods, and manufacturing processes. Apply Quality by Design principles and statistical experimental design and analysis to build product and process understanding and support robust development decisions. 
• Plan, direct, and execute formulation and process-development strategies for new products intended for clinical trials and commercialization. Lead research in sterile product development to advance innovative products and life-cycle management opportunities. 
• Develop and maintain current, in-depth knowledge of global CMC submission requirements and GLP/GMP expectations. Review internal and external technical documents and author technical memoranda, reports, patent applications, and scientific articles. 
• Advance scientific excellence in sterile liquid dosage-form formulation and process development through high-quality technical reports, peer-reviewed publications, professional society participation, regulatory filings, and patents. 
• Collaborate with CROs and CMOs specializing in sterile liquid dosage forms. Manage outsourced development activities, technical deliverables, timelines, and quality expectations in alignment with global regulatory requirements. 
• Represent the department on CMC and project teams, partnering with Pharmaceutical Sciences functions, manufacturing sites, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development, Marketing, and external CROs and CMOs to achieve project objectives and timelines. 
• Interpret and apply current global CMC regulatory requirements and guidance to development programs, technical documentation, regulatory submissions, and responses to health-authority questions in support of product registration. 
• Lead, coach, and develop direct reports by setting priorities, providing timely feedback, supporting career development, and fostering scientific rigor, accountability, collaboration, inclusion, and laboratory safety. Communicate complex scientific and business information clearly in written and oral formats to technical and nontechnical stakeholders