Principal Scientist-Director Bio-Analytical development
ASKGene Pharma, Inc.
Areas of Expertise Desired:
AskGene Pharma, Inc. focuses on development and commercialization of novel and follow on protein theraputics to meet the needs of large patient population. We are seeking a talented and experienced principal analytical scientist to join our southern California unit, US. The qualified individual will play a critical role responsible for analyzing and characterizing therapeutic proteins developed in AskGene.
1.Develop, validate and perform analytical assays to support cell culture, purification and formulation development, and characterization of biological products.
2.Lead and plan entire project activity to meet all analytical requirements of a therapeutic protein development and CMC filing.
3.Interpret data and draw conclusions regarding progress and results of work, utilize the data in appropriate decision making.
4.Manage analytical lab, train junior staff, establish calibration and maintenance of equipment, order and maintain inventory of lab supplies and documentation
5.Write protocols, reports, methods, standard operation procedure, and CMC submission documents
6.Collaborate effectively with other groups, including Upstream, Purification, Quality and Regulatory
We offer competitive compensation including salary, bonus medical and other benefits, depending on experience and qualifications.
Please send your cover letter and resume to firstname.lastname@example.org
1.Ph.D. or M.S in Biochemistry, Chemistry, or other Life Science discipline
2.Ph.D. with minimum 5 years, and M.S. with minimum 8 years experience in therapeutic protein analysis.
3.Experience must be in developing analytical methods for proteins, including, but not limited to, Ion exchange HPLC, SEC, SDS-PAGE, peptide mapping, reverse phase HPLC, CE, glycosylation assay, mass spectrometer, amino acid analysis, host cell protein assay and DNA assay.
4.Good understanding of USP methodologies, ICH Guidelines, GLP, cGMP and FDA regulations.
5.Excellent writing and oral communication skills and knowledgeable to relevant software used in analysis.
6.Responsible, flexible, capable to meeting team needs with a very dynamic timeline, pay attention to details, highly motivated, innovative, 7.collaborative, be able to work with an extremely dynamic and results oriented team.
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