Designs and executes research & development studies, assay qualifications and test article validations under limited supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and validation activities. Participates in client calls and face to face meetings with assistance by departmental senior staff.
• Designs and executes R&D studies under limited supervision.
• Executes Qualification Protocols (QP) and Validation Protocols (VP) and other GMP methods. Drafts QP or VP under minimal supervision of supervisor or technical lead.
• Drafts test methods/ reagent protocols (RPs)/SOPs. Drafts client protocols under minimal supervision
• Participates in assay transfers to Operations. Serves as trainer for inter- and intra-departmental staff
• Writes research and development reports and ensures data are reported clearly and accurately.
• Reports observations of ongoing tests to appropriate internal staff and clients, as needed.
• Author and execute installation qualification and operational qualification (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.
• 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.
• Participates in client calls and face to face meetings with assistance by departmental senior staff.
• General lab housekeeping, ordering reagents and materials, initiate work orders, as needed
• Initiate and track change controls
• Investigates and responds to equipment out of tolerances (OOTs)
• Performs equipment preventative maintenance (PMs), as needed.
• Responsible for REES/ELPRO monitoring and response
• Thorough understanding of Good Manufacturing Practices
• Maybe required to work Holidays and weekends
• May be required to assist in other departments
• Bachelor's degree with at least 4 years relevant, hands-on lab experience or Master's Degree with 2 or more years of relevant experience.
• Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable.
• Aseptic technique, mammalian cell culture and cell based potency testing experience required.
• Experience in a cGMP environment is highly desirable.
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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.