- Novo Nordisk Inc. (Durham, NC)
- …& components correctly; transferring, counting, FIFO, returns, etc. Participate actively in & support event response Review & author SOPs & other documents as ... required Identify, report & resolve quality issues Execute &/or assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance Train fellow employees in areas of expertise & aggressively learn systems &… more
- Merck & Co. (Durham, NC)
- …focus on the daily quality control lab operations.- Responsibilities Support routine release testing Complete appropriate documentation supporting testing ... of assigned activitiesComply with company health and safety procedures and practices. Author SOPs and technical documents Other duties as needed Education Requirement… more
- Merck & Co. (Rahway, NJ)
- …development plan and Investigational New Drug applications.Providing clinical development support of business development assessments of external opportunities to ... for investigational drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Merck & Co. (North Wales, PA)
- …and external partners, design non-interventional and data synthesis studies, author study protocols, develop measurement questionnaires, case report forms, data ... in close partnership with local country affiliates and HTA statistics group. Support country affiliates to understand local evidence generation needs, adapt health… more
- Merck & Co. (Rahway, NJ)
- …validation, design controls and device risk management techniques to positively support and influence clinical and commercial combination product development and ... in the program-specific design controls process and design history file development. Author and review relevant portions of the regulatory submissions (INDs, IMPDs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from sites/ IRBs- May provide medical ... the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of...as pre-submissions, end of phase 1/2, and inspections- May support the GCL in planning and executing the overall… more
- Insmed Incorporated (San Diego, CA)
- …purification development and optimization, process characterization, and clinical manufacturing support . As part of this collaborative group, your professional and ... non-supervisory position.ResponsibilitiesExecute technical strategies for purification process development to support pre-clinical and clinical programs at all development stages,… more
- Merck & Co. (Durham, NC)
- …management, change control, site qualification/validation, equipment qualification, and technical support quality for sterile manufacturing of vaccines. The ideal ... align staff activities with department objectivesFUNCTIONAL EXPERTISE:Specific to Technical Support , the Associate Director will be responsible for comprehensive… more
- Aequor (Bothell, WA)
- …and/or validation comply with cGMP and regulatory expectations. POSITION RESPONSIBILITIES: Support Project Lead for method transfer and/or validation internally and ... externally for assigned program(s). Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical… more
- Merck & Co. (Durham, NC)
- …others and contribute to and implement process improvements.This position will support Purification. This is a twelve-hour 2-2-3 position. Alternating weekend ... coverage will be required.Responsibilities Support operations production through start-up and commissioning and qualification through licensure and implementation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory ... which provides a realistic and accurate information to oversee and support vendor qualification program and the relationship with contract organizations. Collect,… more
- Merck & Co. (Rahway, NJ)
- …Company's pipeline. This role may support facility operations, support compliance investigations/change management, author GMP documentation and manage/lead ... interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and...for working directly with the Prep Lab staff to support scientific teams who are using the Prep Lab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in ... such as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports. Support the change management process for validated systems where necessary.Maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical ... the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of...such as pre-submissions, end of phase 1/2, and inspectionsMay support the GCL, if applicable, in planning and executing… more
- Merck & Co. (Rahway, NJ)
- …ensure safety and quality of clinical supplies to augment and accelerate our products. Author and review GxP documentation including but not limited to batch records, ... safety and quality representatives.Foster culture of collaboration, learning and innovation. Support in setting specific and measurable short- and long-term goals.… more
- Merck & Co. (North Wales, PA)
- …marketed Oncology drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug ... in his/her area of responsibility.To accomplish these goals, the Director may: Author detailed development documents, presentations, budgets, and position papers for… more
- Aequor (Bothell, WA)
- …in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of recovery and purification processes for recombinant ... execute bench-scale chromatography and filtration development and characterization studies Support process development for new molecules from platform process fit… more
- Aequor (Bothell, WA)
- …of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes ... and Quality in accordance with company procedures and regulatory requirements. Author , review and/or approve applicable CSV documentation Assist Business Owners and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Subject Matter Expert (SME) for HEPA certification sitewide needs Provides support to cross functional workstreams in development of appropriate measurement methods, ... existing measurement methods, and executing training as required Lead, develop, and support measurement methods in compliance with regulations (ISO 14644, EU Annex… more
- Insmed Incorporated (San Diego, CA)
- …for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will ... standard and critical reagent programs, including creation, qualification, and inventory. Author GxP stability protocols, interim reports, and reports for stability… more
