Scientist, Small Molecule and Biologics Product Development
AbbVieIrvineUpdate time: November 23,2021
Job Description
About AbbVie 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. The Analytical Sciences organization focuses on analytical development of eye care pharmaceutical products. We are responsible for all CMC analytical activities of both NCE and NBE drug substance and drug product. Our scientists work with global and cross-functional teams to support analytical development from pre-clinical studies to product launch. Role Overview The Scientist is responsible for supporting the development, validation, and transfer of analytical methods for the characterization of proteins and peptides. He/She will provide scientific leadership as an expert across the R&D functional groups and in different project teams for the analytical characterization of biological drugs (i.e. proteins, peptides, protein mixtures). He/She independently plans experimental work and executes protocols in support of biologics process development, formulation development, and stability studies. The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new biological products. The individual is also responsible for writing sections or subsections of Technical Reports or Operational SOPs. He/She independently carries out multiple analytical methods to support biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations. Qualifications *Job level will be commensurate with experience. Basic: Ph.D degree in Biochemistry, Analytical Chemistry, or a closely related discipline, and 0-3 years of experience; MS Degree and 5 or more years of experience; Individuals with a BS degree and 7 or more years of experience may also qualify. Practical Experience and strong knowledge techniques as applied to protein analysis, such as HPLC (RP, SEC, HIC, IEX), capillary electrophoresis (SDS-CE, cIEF), and biophysical characterization methods (UV, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, ITC). Possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development. Keep up to date on scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods. Maintain a laboratory notebook in compliance with Good Scientific/ Documentation/ Manufacturing Practices. Strong data organization skills, strong time management skills, effective communication skills, and independent problem-solving ability. Desired: Mass spectrometry (intact mass and peptide mapping) and bioassay (ELISA, Western blots, and PCR) experiences. A good understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment. Experience with analytical test method qualification and validation in a regulated environment. Working knowledge of the requirements of working in a GLP or cGMP environment. Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance Learns fast, grasps the “essence” and can change course quickly when needed Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experiments to drive the science in the field of interest Embraces the ideas of others, nurtures innovation and manages innovation to reality Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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