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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.
Senior Scientist, II - MSAT
Irvine, California Req ID 2202039 Category Research and Development Division AbbVie- 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 AD/Sr Manager will provide biologic DS technical leadership for new products, tech transfer, and marketed product for Operations. In addition, this position will lead/ process tech transfers, process improvements/optimizations, and new technology evaluations.
- 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.
Minimum Requirements:
- MS//PhD in Chemical Engineering or related field is required.
- Minimum 10 -15 years’ start-up, 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.
- Working knowledge of cGMP regulations and agency guidelines.
Essential Skills, Experience, and Competencies
- Demonstrated knowledge of cGMP biologics drug substance/I manufacturing unit operations and regulatory requirements with prior tech transfer lead, CMC team and regulatory submission experience
- Upstream unit operation expertise with downstream processes knowledge; fermentation, ultrafiltration / diafiltrating, purification, and chromatography in cGMP manufacturing environment
- Excellent verbal and written communication and team leadership skills with ability to work in a matrix / cross-functional organizations.
- Results-driven, hands-on approach with high sense of responsibility, ownership and accountability.
- Flexible in work requirements and willingness to accept and embrace change.
- Ability to travel up to 20% of the time to other Allergan/AbbVie sites, vendors and CMOs.
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