Tunnell Consulting • DC
Evaluate capabilities, technologies and products on key advanced development issues related to the area(s) identified;
35 jobs at Tunnell Consulting
Jobs in
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- Tunnell Consulting • DCEvaluate commercial feasibility of a drug development candidate, feasibility of vendor managed inventory and other alternatives to stockpiling MCMs.
- Tunnell Consulting • INTroubleshooting and maintenance of pharmaceutical process equipment, HVAC, air handling, waste handling and other facility systems.
- Tunnell Consulting • INDirect manufacturing and packaging activities in the production of pharmaceutical products per the cGMPs and client specifications.
- Tunnell Consulting • MAAbility to search the professional literature and identify content (data, images, graphs) to be utilized for slide development.
- Tunnell Consulting • PASolid 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.
- Tunnell Consulting • DCUtilize a network of relationships with top-tier venture capitalists to generate high quality and consistent deal flow for BARDA DRIVe.
- Tunnell Consulting • NJManagement of pharmacoepidemiological data Identify and determine efficient data collection approaches and data sources relevant for the questions being investigated.
- Tunnell Consulting • DCClinical-regulatory experience is a plus and international experience, including working in LMIC, is highly desirable.
- Tunnell Consulting • MAInvestigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management.
- Tunnell Consulting • DESupport 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.
- Tunnell Consulting • MDThe 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.
- Tunnell Consulting • MDResponsible for identifying product development issues and actions required for specific product lines and ensuring these concerns are included in request for proposal documentations.
- Tunnell Consulting • MAExpertise 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.
- Tunnell Consulting • DCReview and advise on contract proposals (formally and informally submitted), as requested.
- Tunnell Consulting • MAResponsible for the execution and analysis of experiments and analytical procedures.
- Tunnell Consulting • MDThe contractor shall determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels.
- Tunnell Consulting • PAParticipate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines.
- Tunnell Consulting • PABeing 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.
- Tunnell Consulting • MAParticipate in the technical support of audits at the subcontractors and provides inputs to the management of the CAPAs that follow.
- Tunnell Consulting • NJCommunicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
- Tunnell Consulting • INDevelop and maintain policies and procedures to comply with applicable regulations related to environmental, OSHA requirements.
- Tunnell Consulting • NJEnsures support groups are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Team Leader.
- Tunnell Consulting • DCCMC experts will also coordinate support in science, engineering, and GMP quality operations to adhere to regulatory and ICH GMP guidelines.
- Tunnell Consulting • NJProven ability to proactively identify and propose solutions to operational activities.Can manage routine responsibilities autonomously.