Senior Scientist I, Downstream Process Development
Company: Disability Solutions
Location: Irvine
Posted on: March 12, 2023
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Job Description:
AbbVie is recruiting for a Sr. Scientist I, Downstream Process
Development position in the Department of Neurotoxin & Biologics
Process Sciences (NBPS), at its Irvine, CA site. Position
Description: The Sr. Scientist I, Downstream Process Development
will be an instrumental team member of the NBPS group. The primary
roles of this position are to lead the protein purification and
pre-formulation studies as part of the downstream process
development for natural and recombinant proteins (including
neurotoxins) from bacterial cultures during early discovery and
process development. This hands-on position is responsible for
designing and executing all aspects of protein purification and
pre-formulation studies such as high-through-put screening, process
development, process and protein characterization, process
scale-up/down, and providing technical support for cGMP
manufacturing, quality, and regulatory activities. In particular,
the candidate is expected to establish pre-formulation capabilities
and high-throughput pre-formulation workflows within the NBPS team
to define process compatible buffer conditions, excipients, protein
stability at key steps within the protein purification process. The
candidate will work closely with members of the downstream,
upstream, and analytical development groups in creating a
collaborative environment for advancement of robust manufacturing
processes. The candidate will give guidance to pilot- and
commercial-scale manufacturing groups through scientifically sound
and well-documented experiments in support of pre-clinical,
clinical, and commercial programs. The candidate must have in-depth
knowledge and experience in protein purification and
characterization, including hands-on skills on chromatography,
ultrafiltration/diafiltration, process optimization, process scale-
up/scale-down, and in-depth understanding of techniques for
biophysical characterization and pre-formulation development. The
successful candidate is expected to lead research and development
studies, author research reports and present findings in the
multidisciplinary team environment. The incumbent will represent
the department and participate in cross-functional project team
meetings. This position also requires a desire and ability to work
as an integral part of a team and supporting drug discovery teams
as well as demonstrate a high degree of flexibility, creativity,
and initiative applied to the various duties and aspects of
position. The incumbent will exhibit leadership skills that result
in good performance and career development of junior staff and
possess excellent communication (oral and written) and
interpersonal skills. The position requires the individual to work
with and in areas requiring select agents access (i.e. biosafety
level 2 and biosafety level 3 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's 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. Qualifications
Keywords: Disability Solutions, Irvine , Senior Scientist I, Downstream Process Development, Other , Irvine, California
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