Allergan
Scientist, II, Biologics ARD
Allergan, Lincoln, Nebraska, United States, 68511
Company Description
AbbVie'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 Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .Job Description
AbbVie 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 biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.The Analytical Development – External Programs group within Biologics ARD is responsible for early development (through proof-of-concept) of programs with outsourced analytical activities. The team will work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies to meet analytical deliverables. In collaboration with cross-functional partners, the team supports formulation and process development studies. Key team 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.Key ResponsibilitiesDemonstrate mastery of a broad range of experimental techniques and methods of data analysis.Design and execute method development and participate in method transfer activities.Act as a key technical contact for external parties and lead troubleshooting of equipment and experimental problems.Provide laboratory support for internal formulation and process development studies.Effectively organize and present scientific plans and data.Author technical documents (e.g. methods, protocols, reports), scientific publications, presentations, and regulatory documents.Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.Ensure safety and GxP requirements are met when performing tasks as needed.Ensure timely and GxP compliant delivery of high quality precise data as needed.Qualifications
Bachelor’s Degree (7+ years) or Master’s Degree (5+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development.Demonstrated independent problem-solving ability in science and technical proficiency.Demonstrated ability to learn, understand, and master new experimental techniques.Ability to multitask and work within timelines.Demonstrated scientific writing skills and excellent verbal communication skills.
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AbbVie'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 Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .Job Description
AbbVie 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 biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.The Analytical Development – External Programs group within Biologics ARD is responsible for early development (through proof-of-concept) of programs with outsourced analytical activities. The team will work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies to meet analytical deliverables. In collaboration with cross-functional partners, the team supports formulation and process development studies. Key team 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.Key ResponsibilitiesDemonstrate mastery of a broad range of experimental techniques and methods of data analysis.Design and execute method development and participate in method transfer activities.Act as a key technical contact for external parties and lead troubleshooting of equipment and experimental problems.Provide laboratory support for internal formulation and process development studies.Effectively organize and present scientific plans and data.Author technical documents (e.g. methods, protocols, reports), scientific publications, presentations, and regulatory documents.Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.Ensure safety and GxP requirements are met when performing tasks as needed.Ensure timely and GxP compliant delivery of high quality precise data as needed.Qualifications
Bachelor’s Degree (7+ years) or Master’s Degree (5+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development.Demonstrated independent problem-solving ability in science and technical proficiency.Demonstrated ability to learn, understand, and master new experimental techniques.Ability to multitask and work within timelines.Demonstrated scientific writing skills and excellent verbal communication skills.
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