Eyecare Formulation & Process Director

Allergan; Irvine (CA); On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Paid time off

Job summary

AbbVie in Irvine, CA is seeking a Principal Research Scientist II / Associate Director to lead sterile liquid dosage form development for eyecare products. You will guide formulation, process development, regulatory readiness, and cross-functional collaborations to enable clinical supply and commercialization.

The role emphasizes scientific leadership, advanced CMC expertise, and the ability to manage CROs/CMOs while ensuring compliance with GLP/GMP and global regulatory standards.

Qualifications

• 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.

Responsibilities

• Provide scientific and technical leadership for development of sterile liquid dosage forms and eyecare products, including formulation and analytical methods.
• Plan, direct, and execute formulation and process-development strategies for products for clinical trials and commercialization.
• Develop and maintain knowledge of global CMC submission requirements and GLP/GMP expectations; review technical documents and author technical memoranda and reports.
• Advance scientific excellence in sterile dosage-form formulation and process development through reports, publications, and regulatory filings.
• Collaborate with CROs and CMOs; manage outsourced development activities, timelines, and quality against regulatory requirements.
• Represent the department on CMC and project teams; coordinate with Manufacturing, Regulatory, Quality, Clinical Development, Marketing, and external partners.
• Interpret and apply global CMC regulatory requirements to development programs and regulatory submissions.
• Lead, coach, and develop direct reports, communicating complex scientific information to technical and nontechnical stakeholders.

Education

Bachelor’s Degree in Science related field

Master’s Degree Science or PharmD

PhD in Science or related field

Job description

AbbVie in Irvine, CA is seeking a Principal Research Scientist II / Associate Director to lead sterile liquid dosage form development for eyecare products. You will guide formulation, process development, regulatory readiness, and cross-functional collaborations to enable clinical supply and commercialization.

The role emphasizes scientific leadership, advanced CMC expertise, and the ability to manage CROs/CMOs while ensuring compliance with GLP/GMP and global regulatory standards.