Supervises the day-to-day viral clearance operations (employees, resources, and capacity) to ensure execution of testing support services. Oversees the performance of the team to perform routine adventitious virus testing according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Holds the team accountable to operational and performance metrics. Strong technical understanding of cell culture processes. Acts as Study Director and/or training coordinator as required.
• Manages, plans and reviews operations for assigned staff, including scheduling, capacity and maintaining standards.
• Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems.
• Conducts employee performance appraisals in a timely and objective manner.
• Provides strong in-house guidance on science and technology.
• Interacts with Project Management to discuss project planning and testing issues.
• Responsible for team members who conduct assays in accordance with GLPs or cGMPs.
• Assures that laboratory personnel are following all company SOPs and safety rules.
• Prepares and revises technical documents (Client Protocols, SOPs, etc.).
• Assures that batch records and other paperwork are completed according to GLPs / cGMPs and company SOPs. Effectively communicates and defends science through written and verbal communication.
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
• Ability to work in a team environment and independently as required
• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education
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.