Scientist II,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.
Independently author process validation documentation and process-related regulatory documentation. Support regulatory approval of biologics. Provide technical input to validation-related activities to enable regulatory submission. Serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.
- Author process validation documentation, including process validation master plan, process performance qualification protocols and reports.
- Author sections of regulatory documents, including INDs, BLAs, briefing packages and responses to regulatory inquiries.
- Provide technical input to validation-related activities to enable robust regulatory submission, including areas of process development, process characterization, tech transfer and process validation.
- Support process development strategy for internal programs and external collaborations to ensure cross-functional alignment and delivery of comprehensive development package.
- Apply process technical knowledge to support problem-solving during process development and validation.
- Serve as a lead scientist within his/her own project and provide technical expertise on one or more project teams.
- Contribute on program acceleration and increased efficiency initiatives.
- BS or equivalent education in Biochemistry or Chemical Engineering and 6+ years of experience; MS or equivalent education in Biochemistry or Chemical Engineering with 4+ years of experience
- Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development.
- Experienced supporting manufacturing process development activities, including process characterization studies, process scale-up, and technology transfer.
- Experienced authoring validation documentation, validation activity support, and troubleshooting.
- Demonstrated knowledge of scientific and regulatory requirements for implementation of post-approval process changes.
- Demonstrated outstanding writing and technical communication skills, including experience authoring validation and regulatory documentation and successful authoring of responses to regulatory questions.
- Demonstrated ability to function as a lead scientist on his/her project, generating technical ideas and research or development strategies.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.