Principal Research Scientist - Process Validation and Process Regulatory Strategy
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Title: Principal Research Scientist I Process Development
Direct and lead process validation activities and guide strategy for process development to support regulatory approval of biologics. Independently author process-related regulatory documentation. Direct project activities by effectively guiding scientific personnel. Independently conceive, execute, and communicate novel ideas to improve process development and validation strategy to achieve project and area goals. Serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.
• Guide process development strategy for internal programs and external collaborations to ensure cross-functional alignment and delivery of comprehensive development package. Provide guidance for cell culture and purification process characterization, applying QbD principles.
• Direct and lead process validation activities, including strategy development and validation documentation.
• Primary author of regulatory documents, including INDs, BLAs, briefing packages, and responses to regulatory inquiries.
• Manage and drive project timelines to ensure successful process validation, regulatory submission, and launch.
• Apply manufacturing process technical knowledge to support problem-solving during process development and validation.
• Guide and mentor scientific personnel to support area goals and team development.
• Effectively function as a principal investigator, generating original technical ideas and research or development strategies.
• Independently responsible for project science within her/his area of expertise on one or more project teams.
• Generate new scientific and capability development proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• BS in engineering or scientific discipline or equivalent education and 14+ years of experience; MS in engineering or scientific discipline or equivalent education with 12+ years of experience; PhD in engineering or scientific discipline with 6+ years of experience.
• Demonstrated broad knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development from early development through commercialization.
• Experience leading biologics manufacturing process development activities, including process characterization studies, process scale-up, and technology transfer.
• Experience leading and guiding process validation activities including development of validation strategy, authoring of validation documentation, validation activity support, and troubleshooting.
• Demonstrated knowledge scientific and regulatory requirements and strategy for phases of development from early development through post-approval management.
• Demonstrated outstanding writing and technical communication skills, including experience authoring validation and regulatory documentation.
• Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies.
• Demonstrated creative 'out of the box' thinking to solve difficult technical problems and champion new technologies/approaches to achieve project goals.
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Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.