Principal Scientist I, PDS&T Analytical CMC Development
AbbVie
Summary
AbbVie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control strategy for late-stage development of biologics. The Analytical CMC Strategy team is responsible for ensuring late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross-functionally with process development, regulatory, and quality within the AbbVie network. This role requires a strategic thinker with a strong technical analytical background in biologic therapeutics, manage complex projects, and effectively communicate cross-functionally.
Job description
Responsibilities
- Drives overall analytical control strategy, including justifying appropriate specifications, determining critical quality attributes, assessing product shelf-life, and risk-based comparability strategies for the biologics pipeline.
- Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities.
- Lead analytical sub-teams, translating development objectives into actionable analytical activities.
- Interpret and identify data trends in key analytical release and stability assays.
- Communicate project strategy, key issues, and risks to relevant teams and escalate risks and facilitate resolution within/across functional areas.
- Actively participate in yearly FTE planning across the analytical organization.
Qualifications
- BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
- Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies.
- Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
- Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
- Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
- Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
Requirements
- BS or equivalent education with typically 14+ years of experience
- MS or equivalent education with typically 12+ years of experience
- PhD with typically 6+ years of experience in area or scientific area of discipline
- Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies
- Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals
- Recognized and sought out as an expert in his/her discipline within the company and possibly externally
- Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents
- Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.