Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation.
This position is responsible for leadership in developing strategic plans for pharmaceutical and biologics development that integrate regulatory requirements, guidance, and expectations to facilitate approvals in global markets.
This position serves as the principal expert on all technical and regulatory matters associated with the company’s infectious agent risk management programs supporting pharmaceutical or medicinal product business interests. The incumbent is expected to have a broad perspective on specific technical and regulatory issues that are relevant to Company objectives. This position will develop, implement, and set priorities and communicate the Company’s infectious agent risk management strategy.
The Lead/Manager is the SPL site lead for cutting-edge molecular technology assays and risk management for potentially infectious agents associated with biologically sourced medical products.
In this role the Lead/Manager is responsible for developing and implementing quality control assays supporting release testing of products manufactured at SPL. Further, the Program Lead is responsible for developing tools and methods for surveying environmental factors and risks associated with biologically sourced raw materials.
• Provide strategic direction and tactical focus to the infectious agent risk management approach across the business. Provide strategic and tactical leadership to integrate risk management plan and regulatory requirements into pharmaceutical and biological development programs.
• Responsible for implementing systems that support the Company’s overall infectious agent risk management program that meets cGMP compliant regulatory standards. Maintain knowledge of new approaches and technologies to ensure regulatory requirements are considered and appropriate strategies are developed. Provide expertise in translating risk management plans and regulatory requirements into practical, workable actions
• Possesses knowledge of current techniques and applications to develop scientifically sound, data-based risk management plans for potential risks associated with infectious agents that maybe associated with biologically sourced medicinal products. Develop and implement strategies for earliest possible regulatory approvals.
• Develop and implement communication and training programs in connection with the Company’s infectious agent risk management plans, strategies, and processes. Conduct internal and external benchmarking to identify best practices and assists with implementation.
• Epidemiological monitoring for viral or other pathogens.
• Inactivation studies in support of SPL products or customer specific.
• Quality control tests for pathogens, qPCR, and next generation sequencing.
• Active participation in external technical and regulatory related activities and organizations affecting or impacting the business.
• Develop comprehensive risk management plans within FDA, EU, ICH, or other applicable guidelines.
• Develop risk management programs to identify, mitigate, and control risks due to potential infectious agents (microorganisms, viruses, prions, parasites).
• Use current technologies and science to characterize, quantitate, and define potential risks due to potential infectious agents.
• Develop cutting-edge quality control methods for detection, identification, and controls.
• Design of applicable models, data bases, and other scientifically sound protocols (for example, inactivation studies for verification or validation) or approaches to implement risk management plans.
• Overall leadership for one or more departments.
• Responsible to lead by example and set the tone for a professional environment.
• Positively engage others in learning and ensuring timely execution of tasks.
• Partner with other senior management to provide leadership to the overall organization.
• Responsible for providing direct and indirect supervision of staff on technical issues related to technologies and methods for infectious agent risk management in medicinal products.
• Leadership in developing strategic plans for pharmaceutical and biologics development that integrate regulatory requirements, guidance, and expectations to facilitate approvals in global markets.