Principal Research Scientist II/ Associate Director- Eyecare
AbbVie
AbbVie seeks a Principal Research Scientist II/Associate Director to lead formulation and process development of sterile liquid eyecare products. The role directs development from early research through commercialization, managing teams and collaborating across functions to advance innovative products while ensuring regulatory compliance.
Responsibilities
- Provide scientific and technical leadership for sterile liquid formulation, analytical methods, and manufacturing processes
- Direct formulation and process-development strategies for new products and life-cycle management programs
- Author technical documents, regulatory submissions, and patent applications in support of product registration
- Lead, coach, and develop direct reports while fostering scientific rigor, accountability, and laboratory safety
- Collaborate with internal departments and external partners to achieve project objectives and timelines
Requirements
- Bachelor's degree in science with 16 years of related experience, or Master's/PharmD with 14 years, or PhD with 8 years
- Proven track record developing and manufacturing sterile liquid dosage forms with approved products
- In-depth knowledge of sterile liquid formulation, manufacturing processes, and global CMC regulatory requirements
- Experience managing technical activities with CROs and CMOs for sterile products
- Proficiency with Quality by Design principles and statistical software like JMP
- Strong knowledge of FDA, EMA, ICH CMC guidance and GMP requirements
- Demonstrated supervisory experience coaching scientific staff and leading cross-functional teams
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