Overview

Performs any basic to complex Analytical assay(s) 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 Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. Sufficiently competent in science to initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated projects. Performs and thoroughly documents Research & Development activities as required.

Responsibilities

• Performs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines, and SOPs using appropriate laboratory techniques.
• Experience with Sanger Sequencing or STR technologies highly preferred.
• Experience operating the 3500xl Genetic Analyzer (or similar) is desired.
• Familiarity with analyzing Sanger sequencing data including building consensus sequences is preferred.
• Experience with NGS technologies a plus.
• Provides technical expertise during process optimization and equipment troubleshooting.
• Executes test article/method and equipment validations.
• Analyzes scientific data with accuracy and precision.
• Possesses sound scientific knowledge and understanding of sequencing assays.
• Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
• Expert on all aspects of assigned processes.
• Works on complex assignments per written procedures where independent action and a high degree of initiative are required in resolving problems and making recommendations.
• Works with minimal supervision from supervisor or Technical Reviewer.
• Contributes to the achievement of company and departmental goals and objectives.
• Authors and reviews non-compliance reports, laboratory investigation reports, SOP and Test Method revisions to ensure documents are accurate and complete.
• Provides training and operational guidance to junior staff and provides performance feedback to Management.
• Adheres to and understands the importance of current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), and Good Documentation Practices (GDP).
• Reviews data entries in lab notebooks, instrument logbooks, and lab cleaning forms to comply with regulatory requirements.
• Initiating and assisting the completion of NCEs and LIRs within the MasterControl environment with minimal assistance of a technical reviewer or supervisor.
• Identifies and escalates scientific and/or quality issues to Senior Management when appropriate.
• Maintains reagent inventories to ensure seamless operations and preparation of primers/probes/standards/reagents as needed.
• Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance.

Qualifications

• A minimum of 4 or more years of relevant experience or equivalent
• Bachelor’s degree with major in Biology or related Science major.
• Relevant prior work experience with nucleic acid techniques including end-point and/or quantitative PCR is required.
• Experience with Sanger Sequencing or STR technologies highly preferred.
• Experience operating the 3500xl Genetic Analyzer (or similar) is desired.
• Familiarity with analyzing Sanger sequencing data including building consensus sequences is preferred.
• Experience with NGS technologies a plus.

Our Values:

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.