NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.
Job: Scientist, Advanced Recruiting Partners, Raleigh, NC
Raleigh, NC 27709 United States
- Health Benefits
- Life Insurance
- Dental and Vision
We are looking for 1 ROCKSTAR scientist for a Biotechnology company. This will be a 6 month contract with potential to go perm. See below for details on this exciting position and APPLY TODAY!!! We will be holding interviews this week!!
The individual in this role is responsible for leading Analytical Chemistry projects and activities related to assay development, qualification, phase-appropriate validation testing, and characterization of PVSRIPO viral product. This role functions in both development and GLP/GMP settings.
• Subject matter expert in chromatography, ELISA, PCR based molecular methods and cell-based methods development for biologics and/or vaccines.
• Involve in design and implement analytical control strategy for viral projects.
• Develop and transfer of analytical chemical release and stability assays in support of PVSRIPO, 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 project workstreams internally, at other sites and at external manufacturers test-ing requiring initiative and judgment.
• Supervise third-party SMEs, scientists/associates and/or the work of technical staff assigned to the project.
• Responsible for set-up, organization and strategic/technical/scientific direction of own work and the CMC team.
• Perform hands-on experiments to accelerate and or troubleshoot third-party based laboratory activities.
• 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.
• Ph.D. with 6+ years' experience; MS with 10+ years' experience or BS with 12+ 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 4 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 biologics: proteins, virus like particles or viral gene vectors.
• Good understanding of cGMP, GLP, pharmacopea testing and regulatory requirements for filing and registration of vaccine and/or biologics.
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North Carolina Biotechnology Center