Principal Research Scientist II/ Associate Director- Eyecare
AbbVie
September 02, 2026
Remote friendly (Irvine, CA)
United States
$141,500 - $268,500 USD yearly
Clinical Research and Development
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, from early research through clinical supply, technology transfer, regulatory submission, and commercialization. Leads a team of scientists responsible for formulation, process, and associated analytical-method development.
Responsibilities:
- Provide scientific/technical leadership for sterile liquid dosage forms and eyecare products, including formulation, analytical methods, and manufacturing; apply Quality by Design and statistical experimental design.
- Plan and execute formulation/process-development strategies for clinical trials and commercialization; lead sterile product research and life-cycle management.
- Maintain knowledge of global CMC submission requirements and GLP/GMP expectations; author technical documents (memoranda, reports, patent applications, articles).
- Drive scientific excellence via technical reports, publications, professional society participation, regulatory filings, and patents.
- Collaborate with CROs/CMOs; manage outsourced development deliverables, timelines, and quality expectations.
- Represent the department on CMC and project teams across internal functions; interpret/apply global CMC guidance for submissions and health-authority responses.
- Lead, coach, and develop direct reports; communicate complex information to technical and nontechnical stakeholders.
Qualifications:
- BS in a science-related field +16 years; MS in science or PharmD +14 years; PhD +8 years.
- Proven innovation with new/improved product releases.
- Ability to work effectively with diverse internal/external collaborators.
Preferred:
- Track record developing/manufacturing sterile liquid dosage forms; experience with sterile product development, tech transfer, and global CMC.
- Experience with CROs/CMOs; scale-up and tech transfer.
- Experience with QbD and statistical design (e.g., JMP).
- Knowledge of characterization techniques and raw-material impacts.
- FDA/EMA/ICH CMC and GMP experience; supervisory experience in development and compliance.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Long-term incentive programs eligibility.
Responsibilities:
- Provide scientific/technical leadership for sterile liquid dosage forms and eyecare products, including formulation, analytical methods, and manufacturing; apply Quality by Design and statistical experimental design.
- Plan and execute formulation/process-development strategies for clinical trials and commercialization; lead sterile product research and life-cycle management.
- Maintain knowledge of global CMC submission requirements and GLP/GMP expectations; author technical documents (memoranda, reports, patent applications, articles).
- Drive scientific excellence via technical reports, publications, professional society participation, regulatory filings, and patents.
- Collaborate with CROs/CMOs; manage outsourced development deliverables, timelines, and quality expectations.
- Represent the department on CMC and project teams across internal functions; interpret/apply global CMC guidance for submissions and health-authority responses.
- Lead, coach, and develop direct reports; communicate complex information to technical and nontechnical stakeholders.
Qualifications:
- BS in a science-related field +16 years; MS in science or PharmD +14 years; PhD +8 years.
- Proven innovation with new/improved product releases.
- Ability to work effectively with diverse internal/external collaborators.
Preferred:
- Track record developing/manufacturing sterile liquid dosage forms; experience with sterile product development, tech transfer, and global CMC.
- Experience with CROs/CMOs; scale-up and tech transfer.
- Experience with QbD and statistical design (e.g., JMP).
- Knowledge of characterization techniques and raw-material impacts.
- FDA/EMA/ICH CMC and GMP experience; supervisory experience in development and compliance.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Long-term incentive programs eligibility.