Principal Research Scientist I/Senior Scientist II Biologics Analytical R&D
4 weeks ago
The Analytical Development – External Programs group within Biologics ARD is responsible for early to late-stage development of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and will work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies to meet analytical deliverables for their given development programs. In collaboration with cross-functional partners, the lead will define analytical strategies for formulation and process development studies. Key deliverables include robust analytical methods, clinical supplies release testing and stability studies to establish clinical product dating, product control strategies informed by analytical data and method understanding, comprehensive data packages that drive product and process understanding, and regulatory submission content.
As analytical lead, develop analytical strategies and communicate to Analytical R&D functions and CMC business partners for experimental execution in support of stability studies, product analytical control strategies, comparability studies and extended characterization of biologics.
Collaborate with third party laboratories to ensure CMC timelines are met.
Interpret and identify data trends in key analytical release and stability assays.
Author and/or review key regulatory documents, laboratory data, technical memos and reports.
Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
Demonstrate scientific excellence in analytical characterization of biologics internally and externally and build and foster an active network of consortia collaborations
Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.
Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
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North Chicago, United States AbbVie Full timeJob DescriptionJob DescriptionCompany DescriptionAbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic...
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North Chicago, United States AbbVie Full timeJob DescriptionThe Analytical Development – External Programs group within Biologics ARD is responsible for early to late-stage development of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and will work with external parties on method development, optimization, validation/transfer, and...
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North Chicago, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in...
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Principal Research Scientist I Analytical Chemistry
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Chicago, Illinois, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our...
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Scientist II, Analytical Research
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North Chicago, United States AbbVie Full timeJob DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and...
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Scientist II, Analytical Research
7 days ago
North Chicago, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in...
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Associate, Scientist I/ii
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Chicago, Illinois, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our...
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Principal Research Scientist I/II
1 week ago
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