Company Name: PPD Development, L.P.
Position Title: Research Scientist
Location: 2244 Dabney Road, Richmond, VA 23230
Summary of Duties: Conducts and provides technical guidance on scientific method development and validation projects and other specialty technologies studies. Performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. Designs and executes method development/validation studies independently and interprets and reviews analytical data for self and others and designs and executes immunochemistry procedures as well as assists others in performing multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols. Independently performs method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in immunochemistry. Designs and executes experiments independently for self and others. Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. Leads analytical (procedural and instrumental) troubleshooting sessions. Assists business development group in technical sales and marketing, and presents posters at technical conferences. Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
Qualifications: PhD in Chemical Engineering, Physics, Biology, Biological Science, Pharmaceutical Science, or related field, and three (3) years of experience as a Scientist, Research Scientist, or related role. Employer will also accept a Bachelor's degree in Chemical Engineering, Physics, Biology, Biological Science, Pharmaceutical Science, or related field and eight (8) years of experience as a Scientist, Research Scientist, or related role. Three (3) years of experience with: General Immunochemistry; Laboratory requirements, SOPs, ICH guidelines, USP requirements, and FDA guidance; Technical operating systems, including data analysis software, bioinformatics software, and scientific instrument software; Optimization of analytical methods; Performing root cause analysis for method investigations; Technical writing for Directives, Methods, Reports, and Research Papers; Detection techniques, including ELISA and ECL; and Theoretical and practical principals of immunochemistry. Two (2) years of experience with: Project management.