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Principal Research Scientist I PDS&T
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BioSpace 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. Purpose
The PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead, specifically for parenteral drug product process development and commercial site scale up and tech transfer. Responsibilities
Independently design and conduct critical experiments that further project goals. Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments. Tech transfer activities for parenteral DP from development scale up to clinical/commercial scale. Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches. Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner. Authoring of comprehensive, scientifically sound reports, e.g., development reports or risk assessments that serve as source documents for regulatory submissions. Develop and maintain comprehensive project plans, timelines, and development and/or scale up tech transfer strategy. Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions, and external partners. Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration. Preferred Qualifications
Strong laboratory skills and experience focused on manufacturing process development for monoclonal antibodies, antibody constructs/conjugates, or other parenteral formulations. Knowledge and experience with manufacturing controls for container closure systems, including vials, prefilled syringes, and prefilled cartridges. Scientific problem-solving, experimental design, and trouble-shooting skills. Solid understanding of the various unit operations of aseptic manufacturing for liquid and lyophilized products. Experience in laboratory documentation systems, including ELN, and demonstrated experience with technical report writing. Technical understanding and experience with small molecule products manufacturing, development, quality, and analytics is required. Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Qualifications
BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in the area or scientific area of discipline. Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies. Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Principal Research Scientist I PDS&T
role at
BioSpace 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. Purpose
The PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead, specifically for parenteral drug product process development and commercial site scale up and tech transfer. Responsibilities
Independently design and conduct critical experiments that further project goals. Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments. Tech transfer activities for parenteral DP from development scale up to clinical/commercial scale. Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches. Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner. Authoring of comprehensive, scientifically sound reports, e.g., development reports or risk assessments that serve as source documents for regulatory submissions. Develop and maintain comprehensive project plans, timelines, and development and/or scale up tech transfer strategy. Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions, and external partners. Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration. Preferred Qualifications
Strong laboratory skills and experience focused on manufacturing process development for monoclonal antibodies, antibody constructs/conjugates, or other parenteral formulations. Knowledge and experience with manufacturing controls for container closure systems, including vials, prefilled syringes, and prefilled cartridges. Scientific problem-solving, experimental design, and trouble-shooting skills. Solid understanding of the various unit operations of aseptic manufacturing for liquid and lyophilized products. Experience in laboratory documentation systems, including ELN, and demonstrated experience with technical report writing. Technical understanding and experience with small molecule products manufacturing, development, quality, and analytics is required. Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Qualifications
BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in the area or scientific area of discipline. Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies. Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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