Principal Research Scientist II/ Associate Director- Eyecare

Preferred

• Proven track record of developing and manufacturing sterile liquid dosage forms, demonstrated through approved products, successful regulatory submissions, technology transfers, patent applications, or other significant technical achievements. In-depth understanding of sterile liquid product development is required, including pharmaceutical formulation principles, manufacturing process development, technology transfer, and global CMC regulatory requirements.
• Experience managing technical development and manufacturing activities with CROs and CMOs specializing in sterile liquid dosage forms.
• Ability to establish and maintain effective relationships with management, co-workers and customers and work well in a team environment.
• Experience leading manufacturing process scale-up and technology transfer for sterile liquid dosage forms from development through commercial readiness.
• Experience applying Quality by Design principles and statistical experimental design and analysis, including the use of JMP or comparable statistical software, to formulation and process development.
• Working knowledge of characterization techniques used to assess critical quality attributes of sterile liquid dosage forms, together with comprehensive knowledge of raw-material properties and their effects on product performance, stability, processability, and manufacturability.
• Strong working knowledge of FDA, EMA, and ICH CMC guidance and GMP requirements, with demonstrated experience preparing or supporting global regulatory submissions.
• Demonstrated supervisory experience, including setting priorities, allocating work, monitoring progress against project timelines, coaching and developing scientific staff, resolving technical and operational issues, ensuring complete and accurate laboratory records, and promoting compliance with laboratory safety and quality requirements.