Technician in Remote Viral Clearance and AKTA Maintenance, 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). Serves as a point person to help organize work flow, resources, and day to day lab responsibilities. Sufficiently competent in science to serve as a Qualified Trainer as needed.
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 Explorer, Avant 150 and Avant 25 FPLC systems.
• Lead 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.
• Coordinates with Remote Viral Clearance 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. Initiation of Change Controls when appropriate.
• Aid in the training of new employees as a qualified trainer.
• Initiate and write nonconformance reports and laboratory investigations as required.
• Verify that all executed Test Methods are accurate and complete prior to submission for review.
• May be called upon to write Testing Methods and Standard Operating Procedures.
• Take a leading role and participate in internal and external R&D projects and collaborations/ validations relevant to the Remote Viral Clearance Group
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
May be required to work overtime, holidays, and weekends as required.
• Contributes to the overall operations and to the achievement of departmental goals
• Thorough understanding of Good Laboratory Practices and Good Documentation Practices
• Performance of other duties as assigned and may be required to assist other departments as needed.
Experience / Education:
• At least 3 years of relevant experience or equivalent
• Bachelors’ degree in Biological Sciences or science related field or equivalent experience
• Previous Laboratory experience with a strong emphasis on column chromatography and nanofiltration.
• AKTA FPLC and Unicorn Software experience is a must.
Knowledge / Skills / Abilities:
• Possesses thorough knowledge of functional equipment
• Knowledge of GDP, GLP and cGMP preferred
• Effective multi-tasking skills and time management required
• Ability to evaluate technical data and record data accurately and legibly
• Ability to understand and follow verbal and demonstrated instructions
• Ability to clearly express and exchange ideas by means of verbal and written communication
• Ability to work effectively as part of a team and exhibit effective interpersonal skills
• Ability to work under limited supervision and to handle problems of a difficult nature
• Proficient in Oral & Written communication skills
• Proficient in Microsoft (Excel, Word, Outlook)
Equal Opportunity Employer Minorities/Women/Veterans/Disabled