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Senior Scientist – S&T Pharm Tech Biologics
AbbVie (ABBV) is a company that will inspire you to aim high with your ambition. Where you can build bridges, power ideas that drive change and drive results for customers and patients. Power your future and join our bold team.
The AbbVie S&T Pharmaceutical Technology Biologics organization at the Allergan site in Irvine, CA is seeking a highly motivated and experienced Senior Scientist to join the Process team. This individual will advance AbbVie’s toxins pipeline and commercial products through efficient tech transfer of robust bioprocesses suitable for cGMP drug substance (DS) manufacturing. The selected candidate will also have a significant role in process optimization - focused on new process steps, methods and technologies that significantly improve process performance. A strong candidate will have in-depth experience in biologic drug substance manufacturing processes and demonstrated skills in process optimization and advancing projects both independently and as a key member of collaborative, interdisciplinary teams.
- The successful candidate will be a key member of the Pharmaceutical Technology Biologics Process group in Irvine California, within the Science and Technology organization (S&T). The Senior Scientist will provide biologic technical support for new products, tech transfer, and marketed product for Operations. In addition, this position will lead, process improvements/optimizations, and new technology evaluations.
- As an individual contributor in a highly matrixed cross-functional organization, lead execution of S&T Biologics Process projects; delivering robust and compliant solutions, improving processes and equipment within regulated guidelines, while meeting business needs, timelines and budget.
- Support existing commercial Biologic API processes, pipeline products, including optimizations and technology transfers; supporting Commercial and Clinical Phase Manufacturing, Process Development and Regulatory. Also, providing cross-organizational support to; R&D, Engineering, Manufacturing, Validation and Quality.
- Support planning and execution of strategic initiatives/projects, process improvements, investigations, risk assessments and change management.
- MS//PhD in Chemical Engineering, biologic sciences or related field is required.
- Minimum 6 years’ tech transfer, and/or manufacturing technical lead experience in biologic drug substance in regulated cGMP biologics industry; upstream and single use technology expertise preferred.
- Team leadership and project management skills to successfully implement projects preferred.
- Working knowledge of cGMP regulations and agency guidelines.
Essential Skills, Experience, and Competencies
- Demonstrated knowledge of cGMP biologics drug substance manufacturing unit operations and regulatory requirements with prior tech transfer, CMC team and regulatory submission experience. Upstream and downstream unit operation expertise with knowledge in; fermentation, ultrafiltration /diafiltrating, purification, and chromatography in cGMP manufacturing environment.
- Thorough practical and theoretical understanding of biologic DS processes to enable cGMP biotherapeutics manufacturing and associated areas of expertise (e.g., cell and molecular biology, process development, process scale up and scale down, protein characterization). Familiar with bioreactor and purification operations, and statistical data analysis tools.
- Excellent verbal and written communication and team leadership skills with ability to work in a matrix / cross-functional organizations. Effectively present scientific data and concepts to various levels of the organization. Author and review technical reports, protocols, and other key documents.
- Results-driven, hands-on approach with high sense of responsibility, ownership and accountability. Self-motivated with excellent attention to detail and ability to multi-task. Strong organizational, planning and trouble-shooting skills.
- Work collaboratively and cross-functionally on multiple projects with colleagues in other functional areas to meet team and company goals. Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Flexible in work requirements and willingness to accept and embrace change. Proactively seek out new information and opportunities to advance our technologies and pipeline. Critically evaluate relevant scientific, regulatory, and business advances and integrate this knowledge.
- Understand and adhere to corporate standards regarding code of conduct, documentation, safety, appropriate handling of materials, and GxP compliance.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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.