Protein Science Director

Specific Responsibilities Include

* Lead and develop scientific staff responsible for characterization of protein reagents and drug candidates using a variety of techniques including light scattering, capillary electrophoresis, gel-based electrophoresis, chromatography, ELISAs, and other biochemical and biophysical
* Guide efforts to develop and qualify physicochemical methods for protein-based
therapeutic
* Guide efforts to support purification, characterization and modification of protein
reagents used by Bioanalytical
* Direct efforts to maximize operational effectiveness of the laboratory including continuous improvement in work practices, testing procedures, and employing GxP compliance when
* Guide efforts to develop new cutting-edge technologies for improving efficiency or increasing depth of biochemical and biophysical knowledge about drug
* Assist in transfer of methods to Quality Control group and external
* Ability to thoroughly analyze results and methods, solve analytical problems,
troubleshoot assays and meet regulatory expectations for
* Maintain effective communication with groups within Preclinical Development, QC, and
* Draft, edit and review standard operating procedures, technical reports, qualification protocols and reports, CMC regulatory filings, scientific journal publications and
* Ability to manage resources effectively to complete corporate deliverables on
* Participates on cross-functional development teams. Provides high-level vision related to protein therapeutic development strategy. Brings experience and understanding of pharmaceutical industry trends and regulatory directions.

Qualifications

* Graduate degree (MS or PhD) or equivalent in biochemistry, biophysical chemistry, or related field with 10 years of progressive industrial experience is
* Experience in supervising a group with accountability for individual performance management (i.e., setting goals and expectations, conducting performance reviews) is
* Strong scientific background in protein analysis with hands-on laboratory experience in the biochemical or biophysical characterization of proteins is
* Experience in a GxP environment is
* Experience in developing and qualifying analytical methods, experience with monoclonal antibodies or other proteins and experience with other protein characterization techniques are
* Experience leading technical teams, drafting technical reports and supporting CMC regulatory filings, and publishing in peer-reviewed journals are
* Excellent written and verbal communication skills and the ability to work in a cross functional team environment are
* Hands-on laboratory experience with liquid chromatography (FPLC, HPLC, and UPLC), static light scattering, capillary and gel-based electrophoresis are highly desirable. Other biophysical methods such as CD, DSC, fluorescence, and AUC are preferred.

Please respond with your information to b.ross(@)realstaffing.com for more information and to apply for the role! Thank you so much for your time and interest.
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