About this role
Position Description:
The incumbent in this role will support the formulation & process development of protein biologics for clinical stage molecules with a specific focus on highly potent molecules for therapeutics and aesthetic use.
This position requires laboratory work in areas requiring select agents and highly-potent-compound 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
Design 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 in vivo studies. Conduct clinical in-use studies to guide dose 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. Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug product development. Accurately document and report experiments in full compliance with GSP standards BS with a minimum of 3-5 years or MS with a minimum of 0-2 years of industry experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry. This opportunity will not consider applicants with a PhD. CMC development experience in protein formulation, drug delivery, or analytical functions is preferred. Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail oriented. Hands-on experience with analytical techniques used for protein characterization and stability studies (e.g HPLC, CE-SDS, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher) are preferred. Prior experience with drug product manufacturing processes and lyophilization are desirable. Excellent communication skills are required. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Candidates based in Southern California are encouraged to apply. Relocation assistance is not guaranteed for those not living in a commutable distance to Irvine, CA or willing and able to self-relocate. The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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