Allergan Scientist- Biophysical Characterization in Irvine, California
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
What Your New Manager Wants You To Know
The Scientist is responsible for supporting the development, qualification, transfer and validation of analytical methods for the characterization of proteins and peptides. This position will have an emphasis in Biophysical Characterization (UV, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, ITC) and mass spectrometry (intact mass, LC-MSMS). 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 and currently marketed biological products. The individual is also responsible for writing sections or subsections of Technical Reports and Method 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.
• Execute the development of analytical techniques for the characterization of biopharmaceuticals with an emphasis on biophysical and mass spectrometry-based characterization. Create written procedures and protocols. Transfer, qualify or validate analytical methods as needed. Mentor staff within a matrix environment when needed.
• 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 AbbVie 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 reasonable and necessary equipment.
• Keep up-to-date on current and cutting-edge developments in the biologics characterization field.
• 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.
Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
PhD in Biological Science, Biochemistry, Protein Chemistry, Biochemical/Chemical Engineering or a related Life Science field with 0-2 years of relevant industrial experience or MS with 2+ years or BS with 4+ years of related work experience.
• Extensive experience with the application of biophysical, separation, and mass spectrometric techniques for the characterization of proteins and their degradation and modification products.
• Skilled in the use of multiple types of equipment for the characterization of proteins or peptides
• Working knowledge of the requirements of working in a GLP or cGMP environment is helpful.
• A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• A strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.
In this role, we’re looking for a leader who will:
• Act as an Owner
• Be Excellence Focused
• Act as an Influencer
Equal Employment Opportunity
At Allergan, 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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