Scientist II, Analytical and Formulations Sciences

DescriptionBR/hrPosition Summary:Provides complex analyses within an analytical development laboratory using defined procedures and practices. Performs complex analytical methods and studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities of biopharmaceuticals at all stages of clinical development. Develops, qualifies, and transfers analytical methods. Works with Quality Control and other Operations groups to troubleshoot and improve existing analytical methods. Makes detailed observations and reviews, documents, and communicates test results.Key Responsibilities:Knowledge and experience with a variety of chromatography techniques: reverse phase, size exclusion, affinity, ion-exchange chromatography, and glycan profiling. Experience utilizing chromatography data systems, Empower 3 preferred.Assists with the design of experimental plans based on the defined deliverables.Conducts semi-routine and moderately complex tasks and sample analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.May function as a process subject matter expert in a cGMP environment.Records results in notebook accurately, clearly, and regularly.Assists with preparing protocols, reports, and test methods.Maintains and ensures a safe laboratory environment and work practices.Helps to maintain laboratory and order common supplies.Executes, records, and evaluates experimental data appropriately, including the writing and revising of process development reports and technology transfer protocols as needed.Collaborate with the different functional areas of biologics development including, upstream development, downstream development, manufacturing operations, and project management.Lead project(s) to support analytical activities by participating in the meetings with internal and external stakeholdersAnalytical: Perform various chromatography assays including reverse phase, size exclusion, affinity, and ion-exchange chromatography. Participate in analytical studies to support method and formulation development, structural characterization, comparability, forced degradation, and other development activities of biopharmaceuticals at all stages of clinical development. Develops, qualifies, and transfers less complex analytical methods.Minimum Requirements/Qualifications:Bachelor's degree in biology, chemistry, biochemistry, chemical engineering, or a related field.With Bachelor's degree, a minimum of 4-6 years of experience related to analytical development, QC, process development, or academic laboratory.Relevant industry experience preferred.With a Master's degree, 2-4 years experience required; related industry experience preferred.With a Ph.D. degree, 0-2 years experience required; related industry experience preferred.Other Job Requirements:Adhere to OHS policies and procedures and ensure a safe and healthy workplace environmentApplied knowledge from the experience of applying the principles, concepts, and practices of the discipline.Working knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment preferred. Solid lab skills. Good problem solving and critical thinking skills.Good writing, communication, and presentation skills.Good MS Excel, PowerPoint, and Word skills.Excellent organization and planning skills.Strong attention to detail and ability to adhere to standard procedures.Ability to design and execute tasks and studies based on the deliverables.Ability to analyze and summarize moderately complex scientific data.Ability to properly document work and write reports.Ability to function in a rapidly changing environment.Strong attention to detail and ability to adhere to standard procedures.Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.Ability to make decisions that require choosing between limited alternatives to resolve problems of moderate complexity. Skill/Experience/EducationScientist II, Analytical and Formulation SciencesContingent Hourly (CWHR)-TEM.CWHR.A00