Technician in Viral Clearance Down-Stream Purification who works under the guidance of a Supervisor/Manager. Performs studies and equipment change over according to, and in compliance with, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).
• Conduct viral clearance studies and lab procedures as outlined in testing record and regulatory guidelines.
• Accurately complete testing records and other required documentation according to WuXi’s Good Documentation Practices
• Basic maintenance and inter-study changeover of AKTA FPLC systems.
• Operates in a team-based environment on the execution of nanofiltration and column chromatography steps in the performance of viral clearance studies.
• Report observations of ongoing studies to Study Director or Manager.
• Works with Viral Clearance – DSP Manager and other colleagues to ensure sufficient resources are allocated to complete tasks in a timely manner.
• Preparation of reagents needed to carry out AKTA maintenance and other associated duties.
• Maintenance of equipment and cleaning logs. Review of Change Controls when appropriate.
• May aid in the training of new employees as a qualified trainer.
• Participate in the issuance of nonconformance reports and laboratory investigations as required.
• May be called upon to write Testing Methods and Standard Operating Procedures.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• At least 2 years of relevant experience in downstream purification, chromatography, nanofiltration, or combination thereof.
• Bachelors’ degree in Biological Sciences or science related field or equivalent experience
• Previous Laboratory experience with an emphasis on column chromatography and nanofiltration.
• AKTA FPLC and Unicorn Software experience is a plus.
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.