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Evaluate capabilities, technologies and products on key advanced development issues related to the area(s) identified;
Evaluate commercial feasibility of a drug development candidate, feasibility of vendor managed inventory and other alternatives to stockpiling MCMs.
Troubleshooting and maintenance of pharmaceutical process equipment, HVAC, air handling, waste handling and other facility systems.
Direct manufacturing and packaging activities in the production of pharmaceutical products per the cGMPs and client specifications.
Ability to search the professional literature and identify content (data, images, graphs) to be utilized for slide development.
Solid understanding of, and experience, in implementing and leading tools such as Lean, Six Sigma, Quality Risk Management, Quality Systems Management, Change Leadership and Project Management.
Utilize a network of relationships with top-tier venture capitalists to generate high quality and consistent deal flow for BARDA DRIVe.
Management of pharmacoepidemiological data
Identify and determine efficient data collection approaches and data sources relevant for the questions being investigated.
Clinical-regulatory experience is a plus and international experience, including working in LMIC, is highly desirable.
Investigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management.
Support cell line development, early and late-stage cell culture process development, scale up, technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules.
The contractor shall serve as the technical/programmatic lead on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.
Responsible for identifying product development issues and actions required for specific product lines and ensuring these concerns are included in request for proposal documentations.
Expertise with analytical instrumentation, especially with HPLC, Mass Spectrometry and LC-MS/MS methodology including quantitation using triple quadrupole mass analyzer; the knowledge of GLP environment is a plus.
Review and advise on contract proposals (formally and informally submitted), as requested.
Responsible for the execution and analysis of experiments and analytical procedures.
The contractor shall determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels.
Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines.
Being our quality expert to provide support on any quality issues that come up on any of our projects and to the external world when speaking at conferences.
Participate in the technical support of audits at the subcontractors and provides inputs to the management of the CAPAs that follow.
Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
Develop and maintain policies and procedures to comply with applicable regulations related to environmental, OSHA requirements.
Ensures support groups are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Team Leader.
CMC experts will also coordinate support in science, engineering, and GMP quality operations to adhere to regulatory and ICH GMP guidelines.
Proven ability to proactively identify and propose solutions to operational activities.Can manage routine responsibilities autonomously.