Scientist II
3 weeks ago
The incumbent in this role will lead formulation development studies of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetic use.
This position requires laboratory work 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.
Responsibilities
Lead and 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.
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.
Experience with analytical tools such as SEC, HPLC, in vitro antibody based assays (qELISA, light chain activity assay, analysis of OCTET data, etc), rheology, DLS, HIAC, etc.
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.
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