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, CaliforniaReq ID 2202039Category Research and DevelopmentDivision 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.
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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)