Tunnell Consulting • IN
Direct manufacturing and packaging activities in the production of pharmaceutical products per the cGMPs and client specifications.
48 jobs at Tunnell Consulting
Jobs in
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- Tunnell Consulting • INDirect manufacturing and packaging activities in the production of pharmaceutical products per the cGMPs and client specifications.
- 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 • MDServes as a subject matter expert on medical product development with a full understanding of the procedures and processes necessary to bring a medical technology through the FDA regulated means to approval.
- Tunnell Consulting • MAAnalytical scientist with hands on knowledge of proteomics. Scientist III to assist with developing critical assays for the identification of a small molecule that has Dupilumab type activity in collaboration with the Immunology TA and IDD.
- Tunnell Consulting • NJResponsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international regulations.
- Tunnell Consulting • NJIdentify and determine efficient data collection approaches and data sources relevant for the questions being investigated.
- Tunnell Consulting • MAThe Clinical Data Associate Principal position requires a highly skilled individual, who seeks a technical rather than a managerial career path.
- Tunnell Consulting • Washington, DCProvide Subject Matter Expert (SME) support to BARDA's Interface Office (Ventures, Launch, Accelerators) in the day to day execution and management of dilutive and non-dilutive investments.
- Tunnell Consulting • Washington, DCProvide subject matter expertise (SME) from Discovery through Phase 2 development for novel approaches using technology for early identification of infection.
- Tunnell Consulting • NJApprove safety regulatory and clinical documents including submission, transversal and primary GPE documents as per SOP Information/Decisions to be referred to hierarchy.
- Tunnell Consulting • NJResponsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international regulations.
- Tunnell Consulting • Washington, DCAssist in the development of and utilize pulmonary medical countermeasures landscape and advice to ensure effective and proper portfolio expansion and execution.
- Tunnell Consulting • Washington, DCWork as part of an interdisciplinary team to assist BARDA contractors to develop valid, high-yielding and economical processes and analytical methods for the production of biopharmaceutical products.
- Tunnell Consulting • Washington, DCProvide financial analysis on medical countermeasure products that have both commercial and bio defense indications, specifically identifying the sustainability/viability of a commercial market.
- Tunnell Consulting • INTroubleshooting and maintenance of pharmaceutical process equipment, HVAC, air handling, waste handling and other facility systems.
- Tunnell Consulting • Washington, DCSupport BARDA Program Office(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or diagnostic advanced clinical development; clinical trial and/or regulatory policy pertinent to chemical, biological, radiological and/or nuclear threats.
- Tunnell Consulting • DCAssess and monitor the risks associated with clinical development of medical countermeasures. Inform on any increase / decrease in risk to success of the project and generate contingency risk reduction plans.
- Tunnell Consulting • MDThe contractor shall collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
- Tunnell Consulting • MDRegulatory agency inspections, including sponsor / monitor inspections and clinical investigator site inspections.
- 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 • DCReview, evaluate and support potential products in relation to scientific feasibility, risks and mitigation strategies and requirements for entrance into the enact program and/or other barda programs in alignment with barda's national health security priorities.
- 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 • Philadelphia, PALocal in-country regulations as applicable for provided services. Vendor Policies / SOPs / Work Instructions.
- Tunnell Consulting • Wayne, PAResponsible for technical support for the pharmaceutical development of pipeline products, including serving as the subject matter expert for peptide drug substance manufacture. Expected to proactively identify potential issues and develop effective solutions to technical challenges. Secondary responsibilities include technical support for drug product manufacture.