The Manager would be responsible for the Microbiology laboratory and staff to ensure day-to-day operations are being performed to meet the demands of testing operations. This position will be responsible for GMP Testing. Candidate should have technical expertise in microbiology including Sterility and bioburden testing, laboratory design and commissioning will also be a primary function.
* Manages the team for GMP Microbiology Testing and staff
* Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures
* Responsible for commissioning and planning of a new laboratory and creation of all standard operating procedures and test methods
* Provides training on areas of technical expertise and compliance issues relevant to the lab setting and provides technical support to staff
* Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs
* Accurately completes Test Methods and other required documentation according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs
* Prepares protocols, final reports, investigations, and deviations as needed
* 5+ years relevant technical experience
* Must have experience managing a staff of at least 5 employees
* BS/BA in Science related field preferred; or combination of relevant Experience & Education
* Supervisory Skills and Lab Management
* cGMP experience
* Effective multi-tasking skills and time management required
* Ability to evaluate technical data and record data accurately and legibly
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.