Associate Scientist I - II, Biologics Drug… at Allergan… · Irvine

Summary: AbbVie is a company dedicated to discovering and delivering innovative medicines. The Associate Scientist I - II will support the formulation development of protein biologics, focusing on therapeutics and aesthetic use, while ensuring compliance with regulatory requirements. Responsibilities: - Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms - Manufacture drug product formulation batches for evaluating formulation stability and/or to support animal studies - Conduct clinical in-use studies to guide dose solution administration - Analyze data, interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments accordingly - Generate high-quality data based on sound scientific understanding and prepare formulation data summaries, technical reports, and scientific presentations - Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug product development - Maintain oversight of day-to-day laboratory activities; manage inventory of raw materials and drug product packaging and manufacturing supplies; coordinate ordering, shipping, and receiving Required Qualifications: - Bachelor's degree in chemical engineering, biochemistry, pharmaceutical sciences or equivalent, with 0–3 years of relevant experience for Associate Scientist I - Bachelor's degree in chemical engineering, biochemistry, pharmaceutical sciences or equivalent, with 3-5 years of relevant experience for Associate Scientist II - Prior experience with drug product manufacturing processes and lyophilization is required - Candidates must demonstrate the technical ability to execute and troubleshoot experiments using rational and critical thinking - Must be highly organized and detail oriented - Excellent verbal and written communication skills are required - A strong willingness to learn and apply new scientific techniques Preferred Qualifications: - Experience in handling select agent and highly-potent-compounds is highly preferred - Experience in CMC development, with a preference for protein formulation, drug delivery, or analytical functions - Hands-on experience with analytical techniques used in protein characterization and stability studies, such as HPLC, spectroscopy, HIAC, DLS, ELISA, and Karl Fischer, is preferred Required Skills: Formulation Development, Protein Biologics, Highly-Potent-Compound Handling, Drug Product Manufacturing, Lyophilization, CMC Development, Protein Characterization, HPLC, Spectroscopy, HIAC, DLS, ELISA, Karl Fischer Benefits: Paid time off (vacation, holidays, sick), Medical/dental/vision insurance, 401(k)