Assistant Site Controller

Scientist I (Biologics Drug Product Development), AbbVie Inc., Irvine, CA (onsite 5 days per week): Support formulation development of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization, with a specific focus on neurotoxins for therapeutics & aesthetic use. Execute formulation composition & drug product process development studies for sterile liquids, lyophilized, & pre-filled dosage forms. Manufacture drug product formulation batches for evaluating formulation stability & /or to support animal studies. Conduct clinical in-use studies to guide dose solution administration. Generate high-quality data based on sound scientific principles & prepare formulation data summaries, technical reports, & scientific presentations. Must have BS in pharmacy, chemical or biomedical engineering, chemistry, or biology & 5 years of experience as a scientist working in biologics &/or drug product development. Of experience required, must have 5 years: (i) performing CMC development in drug &/or protein formulation, drug delivery, or analytical functions; (ii) planning & implementing manufacturing process development for biologics &/or various drug products; (iii) applying analytical tools & techniques used for drug &/or protein characterization & stability including: HPLC, spectroscopy, HIAC, MFI, DLS, ELISA, & Karl Fisher; (iv) executing & troubleshoot experiments through rational & critical thinking; (v) developing drug product manufacture processes & lyophilization cycles; (vi) executing & interpreting experiments for formulation & process development; (vii) applying GMP/ GLP principles to all aspects of work; & (viii) working with internal & external cross functional teams. Alternatively, would accept MS in pharmacy, chemical or biomedical engineering, chemistry, or biology & 6 months of experience as a scientist working in biologics &/or drug product development. Of experience required, must have 6 months in each of (i), (iii), (iv), (vi), (vii) & (viii). For points (ii) & (v), would accept graduate level coursework (theoretical understanding) as an alternative. Work experience may be gained concurrently. Employer will accept combination of education, training & work experience. Salary Range: $112,098.26 - $142,500.00 per year. Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49788R
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