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
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, and driving results.
Our department develops analytical methods for the analysis and characterization of neurotoxin biologics in CMC development. We are looking for an experienced and accomplished Senior Scientist with a track record of developing bioassays and functional assays. In particular, the scientist will work on early development of complex bioassays to improve our understanding the kinetics and mechanisms of action of neurotoxin activity.
He/She will primarily work independently to plan experimental work and carry out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.
He/she may also support as a secondary priority biologics process development, formulation development, and stability studies. This includes independently generating, compiling, and evaluating data for technical reports to support regulatory filings for new and currently marketed biological products. The individual may also support writing sections or subsections of technical reports, method and/or operational SOPs. He/She independently carries out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.
The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
• Support development of phase appropriate methods to support toxin development programs.
• Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.
• Represent department for important organization-wide initiatives to support establishment of infrastructures.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
• Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
• Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
• Make high quality scientific presentations at internal management, regional and national meetings to help advance AbbVie’s image as the thought and product leader in the neuromodulator field. Present and defends product, assay and process data to regulatory agencies.
Qualifications
Position will be hired based on level of experience.
• Senior Scientist I: Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Senior Scientist II: Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.
• Strong experience in the area of designing and qualifying in vitro cell-based assays to refle
Location: Irvine, CA
Posted: Aug. 12, 2024, 5:17 p.m.
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