ProClinical is seeking to fill a permanent Biosafety Officer position for a growing company based in Philadelphia, PA. This position affords the opportunity for the right applicant to use their skills and knowledge to build and manage a Biosafety program at several locations on an expanding campus in Philadelphia, which may then be used as a basis for other Biosafety programs at the company’s other locations. 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. Additionally, develop procedures that mitigate biological risks, and own the vaccination program for incoming and current employees.
- Prepare, update, and draft policies, guidelines, and procedures for biological hazards, processes, and emergency response.
- Perform laboratory audits and inspections, select agent inventories, and other duties as assigned.
- Support the import/export of biological agents and permit applications, and the shipment of biological agents and equipment.
- Collaborate with and support general EHS at all locations, inclusive of liaison to safety committees and chair of Biosafety Committee.
- Collaborate with other US locations to further Biosafety within the organization.
- Interface with clients and regulatory agencies for audits and inspections.
- Understand and articulate the business drivers aligned with the Biosafety strategy.
- Develop, implement and deliver Biosafety training to all personnel.
Skills And Requirements:
- 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 in implementing policies and procedures that mitigate biological risks, leading of culture change required to embrace those policy and procedural changes included.
- Experience evaluating, providing advice and implementing solutions due to complexities of Biological safety, training and industrial hygiene issues strongly preferred.
- Proficiency in word processing and document preparation.
- Ability to work some long hours, work off shifts and hours; potentially 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg at (+1) 267 405 6995 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.