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Principal Scientist/Group Leader Analytical Sciences

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Company: None

Location: West Chester, PA

Date Posted: July 4, 2014

Source: IvyExec

We are looking for an experienced scientist and leader with broad knowledge and experience in protein structure, product characterization and assay development. The candidate is expected to be familiar and have practical experience in the following technology/methodology, but not limited to BiaCore binding assays, ELISA, CD, DSC, DLS, AUC and peptide mapping. Training in cell biology or biochemistry is desired. The candidate must be proficient in study design, regulatory filing, protocol and technical report generation. The candidate will be hired for Teva, West Chester site and required some weekly traveling to Rockville site, MD for a short time. ResponsibilitiesThe successful candidate would be capable of fulfilling the following goals within their first year:Define strategy and oversee execution for assessment of Critical Quality Attributes for several biologic products Structure product characterization for a phase III antibody drug candidate through managing work at CRO and internal-testing groupsLead standardization of product ...

We are looking for an experienced scientist and leader with broad knowledge and experience in protein structure, product characterization and assay development. The candidate is expected to be familiar and have practical experience in the following technology/methodology, but not limited to BiaCore binding assays, ELISA, CD, DSC, DLS, AUC and peptide mapping. Training in cell biology or biochemistry is desired. The candidate must be proficient in study design, regulatory filing, protocol and technical report generation. The candidate will be hired for Teva, West Chester site and required some weekly traveling to Rockville site, MD for a short time. ResponsibilitiesThe successful candidate would be capable of fulfilling the following goals within their first year:Define strategy and oversee execution for assessment of Critical Quality Attributes for several biologic products Structure product characterization for a phase III antibody drug candidate through managing work at CRO and internal-testing groupsLead standardization of product characterization process and develop a phase appropriate approachStandardize comparability study approach following regulatory recommendationSet up the analytical lab in West Chester site and hire scientists or associates as appropriateManage 2-3 junior scientists and/or associatesSupport filing BLA for a late phase product by authoring, reviewing, and approving relevant CTD dossiersLead and support FcRn binding assay developmentLead and support method validation and transfer as appropriateQualifications PhD in biochemistry or equivalent ;10 years experience in biotech or biopharm industry with a track record of leadership;Excellent oral and written communication skills are absolutely required;Cooperative, independent, critical thinking, detail oriented and multi-tasking;Knowledge in antibody drug development is preferred. Biotech/R&D/Science

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