Performs Cell Culture, qPCR and Cell-Based assays (BSL2 and BSL2+) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Sufficiently competent in science and may serve as a Qualified Trainer as needed. May have client-facing interaction.
• Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Performs assays using appropriate laboratory techniques for lab group assigned to.
• Reports observations of ongoing tests to Study Director or Laboratory Manager.
• Communicates with supervisor and other colleagues re: daily lab activities.
• Performs daily work activities with minimal supervision.
• Performance of labs upkeep per GLP, cCMP, CFR and/or PTC guidelines and SOPs.
• May author Test Methods, Client Protocols and Operating Procedures
• Author adverse events and reviews batch records to ensure documents are accurate and complete
• Evaluates operating procedures for accuracy and efficient operations and makes corrections as necessary
• Understands the importance of the regulatory compliance requirements for the production of biologics.
• Coordinates with supervisor to move resources, if necessary.
• May serve as qualified trainer and / or training coordinator and may perform classroom trainings.
• Effectively interacts with clients, management, external departments and auditors as required for onsite studies or on the client’s behalf.
• Acts as mentor to Junior Technicians.
• May perform statistical analysis of raw data
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• A minimum of 3 years of relevant experience with a Bachelors’ degree or 1+ years of relevant experience with a Masters’ degree or equivalent
• Bachelors’ degree in Biological Science or other related science field or equivalent experience
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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.