Designs, plans, authors, executes, and leads internal research & development studies in the Analytical Development team. This position specifically focuses on driving method efficiency in Virology and Molecular Biology. Candidate will also author and assist in the execution of assay qualifications under very limited supervision. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and qualification activities.
• Designs, plans, leads, and executes R&D studies under very limited supervision
• Documents research studies with a clearly defined purpose, methods and materials, results, and discussion
• Writes research and development reports and ensures all data are reported clearly and accurately
• Drafts and executes qualification protocols. Author qualification reports
• Drafts method protocols and SOPs
• Participates in assay transfers to Operations. Serves as trainer for inter and intradepartmental staff
• Evaluates new equipment, as needed
• Author and execute IQOQ, author equipment SOP, as needed
• Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs, as applicable
• Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures
• Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting
• Serves as technical reviewer and LIMS tech manager
• Presents data at internal staff meetings
• Orders reagents and materials, as needed
• Initiate and track change controls
• PhD in Biological Sciences with 0-2 years of experience
• Must be highly skilled in quantitative PCR.
• Experience with ddPCR and/or next generation sequencing is a plus
• Experience with qPCR is highly desirable
• Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.