The individual in this role is responsible for leading Analytical Chemistry projects and activities related to assay development, qualification, testing, and characterization of novel viral vaccine candidates. This role functions in both development and GLP/GMP setting. Development projects and activities focusing on characterization of novel viral vaccine candidates.
Subject matter expert in chromatography and other analytical methods development for biological and/or vaccines.
Involve in design and implement analytical control strategy for viral vaccine projects.
Develop and transfer of analytical chemical release and stability assays in support of viral vaccine, upstream and downstream process development, as well as subsequent transfer and implementation of tests within QC labs for both Drug Substance (DS) and Drug Product (DP) development to support clinical trial studies and/or Commercial Manufacturing.
Establish and execute deliverables for analytical assay development, qualification, tech transfer, and validation in collaboration with other groups or other sites; Ensure all deliverables are within schedule and cost through proactive identification of risks and mitigation steps.
Plans and supervises multiple projects internally, at other sites and at external manufacturers test-ing requiring initiative and judgment.
Responsible for chemistry group. Supervise other scientists/associates and/or the work of tech-nical staff assigned to the project
Prepare project update presentations for senior management reviews; contribute to regulatory filings and interactions with health authorities to ensure successful registration of products.
Proactively identify potential issues. Develop creative solutions to technical problems in order to keep projects on schedule.
Identify and evaluate new analytical technologies.
Responsible for set-up, organization and strategic/technical/scientific direction of own work and for associates.
Ph.D. with 6+ years? experience or BS with 12+ years experience, MS with 10+ years experience in related science discipline.
Ph.D. degree in Analytical Chemistry, or related major, with relevant biotechnology/pharmaceutical development experience is preferred.
At least 6 years of relevant work experience in new product development, tech transfer in the biotechnology and/or vaccine industry.
Hands-on and in-depth understanding of wide variety of analytical techniques and associated instrumentation to measure proteins, virus like particles, viral gene vectors or other types of vaccines.
Good understanding of cGMP, GLP, pharmacopea testing and regulatory requirements for filing and registra-tion of vaccine and/or biologics.
Project management experience is preferred.
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