Principal Research Scientist II/ Associate Director- Eyecare

AbbVie•Irvine, CA

7d•$141,500 - $268,500

About The Position

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.

Requirements

Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
Proven ability to innovate with a history of new or improved product releases.
Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.

Nice To Haves

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.

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.