Download Senior Scientist, Pre-Formulation Development

Senior Scientist, Pre-Formulation Development-0018581
Location: Madison, WI
Position Overview:
This Sr. Scientist position will be responsible for leading activities of formulation development. This
position will be capable of screening formulation, performing biophysical characterization testing, and
designing and executing stability studies to support formulation development. The Sr. Scientist will
serve as a formulation lead for technical advice and perform multiple complex projects at a time. This
position is able to design new approaches to attack complicated problems encountered during
formulation development.
Specific Responsibilities:
This position will lead formulation development activities to support early stage drug substance
development. This position will independently evaluate, select and apply advanced analytical
techniques to evaluate and define new formulations to stabilize protein drugs.
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Designs and executes formulation protocols
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Develops/optimizes biophysical techniques for formulation, including HPLC, CE, DSC, MFI, CD,
and light scattering methods to characterize protein/mAb

Performs biophysical testing to support biologics formulation development
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Responsible for designing and executing stability studies
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Troubleshoots and solves HPLC, CE, and other instrument problems

Acts as the technical lead for Client development projects, communicates project status and
effectively provides technical explanation/rationalization
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Critically analyzes complex data, interprets and integrates experimental results with project
objectives

Stays current with respect to the latest advancement in protein analytical techniques and
protein formulation

Accurately ships samples to clients and fills out appropriate paperwork

Makes decisions affecting project directions and maintains project timelines

Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials,
disposal of trash and recyclables, ordering and stocking supplies, etc.
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Accurately completes routine and preventative maintenance on laboratory equipment,
including qualification and calibration
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Actively participates in team meetings
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Mentors others, as assigned
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Performs lab overview for client tours and internal clients (shadowing)
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Other duties as assigned
Qualifications:
Education:

Ph.D. Chemistry/Biochemistry or related with at least 2 year biologics formulation experience
in biotech industry or MS with over 5 year experience

B.S/B.A. with over 8 year experience
Experience:

Experience in early stage formulation development for drug substance

Hands-on experience in developing HPLC/UPLC, CE, DSC, MFI, CD, and light scattering
methods for protein/mAb analysis

Expertise in designing protein stability studies to support protein formulation

Good documentation practices (GDP)

Experience writing standard operating procedures and reports

Experience mentoring junior staff regarding laboratory procedures