More information about this job:
To support the growth of WuXi Philadelphia, WuXi EHS has expanded to fill a Biosafety Officer position. This position will have the opportunity to use their skills and knowledge to build and manage a Biosafety program at all three WuXi locations in the Philadelphia Campus. Ultimately, this framework may be used for the base of a Biosafety program at our Atlanta and St. Paul locations.
The Biosafety officer will be responsible for supporting the development, implementation and maintenance of the WuXi Biosafety Plan across the Philadelphia sites. The Biosafety officer will be integral in the analysis and mitigation of all biological risks associated with facility activities.
• Work with laboratories to integrate Biosafety into Manufacturing and laboratory operations (Inclusive of BSL 1-3 laboratories performing work with biological agents such as rRNA, Gene Therapy, Virology, Microbiology, etc) and promote safe work practices based on regulatory requirements, and best management practice guidance.
• Perform risk assessments of new client processes as part of the New Product Introduction process with regards to equipment, biological agents, protocols, and process applications. Develop procedures to mitigate biological risks and owns the vaccination program for new and current employees
• Prepare, update, and draft policies, guidelines, and procedures for biological hazards, processes, and emergency response.
• Performs laboratory audits and inspections, select agent inventories, and other duties as assigned.
• Supports the process of importing/exporting biological agents, permit applications, shipment of biological agents and equipment.
• Collaborates with and supports general EHS at all PHL locations, inclusive of liaison to Safety Committees and chair of Biosafety Committee.
• Collaborates with other US locations to further Biosafety within the organization.
• Interfaces with clients and regulatory agencies for audits and inspections.
• Be able to understand and articulate the business drivers aligned with the Biosafety strategy.
• Develops, implements and delivers Biosafety training to all personnel (WuXi, Client, Contractor, etc)
• Masters in microbiology or equivalent bioscience discipline.
• 5-7 years' experience in an applied setting preferably involving the coordination and management of a biosafety program.
• Previous experience implementing policies and procedures that mitigate biological risks, including the leading of culture change required to embrace those policy and procedure changes highly desired.
• Experience evaluating, providing advice and implementing solutions due to complexities of Biological safety, training and industrial hygiene issues strongly preferred
• Must be proficient in word processing and document preparation.
• Ability to work some long hours, work off shifts and off hours, potentially work a Saturday.
• Knowledge of: OHSA, EPA, CDC, NRC, DOT, WHO, IATA regulations as they apply to this position.
• Experience in a cGMP environment preferred.
• CBSP, RBP certification preferred.
If Interested send your resume to Mark.Oppenheim@Wuxiapptec.com or Call 215-218-7100 Ext. 5304