Director, Virology and Viral Clearance at Suzhou, China, Biosafety Testing Laboratories
Responsible for establishing and directing the Virology and Viral Clearance testing operations in a new facility in Suzhou, China. Will be responsible for directing the technical transfer of assays and systems from WuXi AppTec’s US laboratories in Philadelphia which have established assays for cell and virus bank testing, raw material screens and release tests. Will also direct the transfer and establishment of viral clearance capabilities, utilizing the systems presently employed in Wuxi AppTec’s Philadelphia site.
The initial period of this position will require training in the Philadelphia site with the US teams for virology and viral clearance, and preparing the processes and documentation to transfer the technology and expertise to the new lab in Suzhou. The second phase will include the hiring and training of staff to perform virus detection assays as well as viral clearance projects.
Regular operations will then include ensuring day-to-day testing operations are performed, while maintaining a rigorous quality mindset with strict adherence to compliance practices within the department. Individual will possess rigorous scientific skills in virology or viral clearance or both, and the applicable regulatory laws and guidelines from the SFDA, US-FDA, and EMA, such as the Good Laboratory Practices (GLP), the current Good Manufacturing Practices (cGMP), and other international compliance requirements.
Remains current regarding biosafety testing requirements and modifies assays to fully address such issues. Remains current in the scientific areas of Viral Clearance, Virology and Cell Biology.
- Prepares or approves client protocols and Standard Operating Procedures (SOPs).
- Ensures testing is scheduled and performed per protocol.
- Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work 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.
- Acts as Study Director for assigned assays and assumes all associated responsibilities.
- Interacts with clients to discuss project planning and testing issues
- Prepare quotations for Virology and Viral Clearance testing projects
- Design of Viral Clearance studies; interpretation of Viral Clearance study results
- Interacts with internal staff to identify assays requiring further improvement or development and oversees improvement of these assays.
- Travels with other WuXi AppTec staff to visit clients as appropriate.
- Presents technical seminars at external professional meetings.
- Responsible for appropriately conducting assays in accordance with GLPs or cGMPs.
- Assures that laboratory personnel are following all company SOPs and safety rules.
- Assures that batch records and other paperwork are completed according to GLPs / cGMPs and company SOPs.
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication; preferably in both English and Mandarin
- Knowledge of GLP and cGMP guidelines is desirable.
- Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
- Ability to evaluate technical data and write technical documents.
- Ability to use judgment as dictated by complexity of situation.
- Ability to work under limited supervision and to handle problems of a difficult nature.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Ability to record data accurately and legibly.
- Ability to understand and follow verbal or demonstrated instructions.
- Ability to express or exchange ideas by means of the spoken word.
- Ability to work effectively as part of a team and to exhibit effective interpersonal skills.