- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Function Team Lead development of strategies for the needs assessment, design , planning, delivery, and evaluation of training across the organization. Work ... governance modelLead training related risk analyses and escalate them to senior leadership in GQAResponsible for development, oversight, and maintenance of GQA… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control ... launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Design ...The Senior Scientist, Device System - Device Design Control will be responsible for device design… more
- Merck & Co. (Rahway, NJ)
- …submissions-and post-marketing support.-The incumbent is responsible for the design and maintenance of statistical datasets that support multiple-stakeholder ... quality- Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in-mind that optimize analysis and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new ... span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design . Lead the team to define Critical to Quality factors, select critical… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Senior Principal Scientist/ Senior Director is responsible for protocol ... for all phases of the trial process, including but not limited to the design , oversight and medical monitoring of Phase I to V clinical trials, preparation of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled syringe delivery device design and function, and the ability to develop robust… more
- Merck & Co. (Rahway, NJ)
- Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for ... Immunology Therapeutic Area Lead in Translational Medicine.Primary responsibilities for the Senior Principal Scientist include the following:Key member of an early… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly motivated Senior Principal Scientist to join our collaborative Biophysics group within the Mass Spectrometry & Biophysics ... group of scientists to drive our core mission. Key Responsibilities: The Senior Principal Scientist, Biophysics will be accountable for:Overseeing a portfolio of… more
- Merck & Co. (Rahway, NJ)
- …domain.Identify customer search needs and translate requirements into IT solutions. Design and implement Enterprise Search solutions leveraging our collaboration ... for customer interactions and other IT functions.Identify capability gaps and design solutions to address those gaps in Enterprise Search capabilities.Contribute to… more
- Merck & Co. (Rahway, NJ)
- …Sterile GMP Clinical Manufacturing facility.Contribute to equipment and facility design , system commissioning/ qualification, regulatory certification, as well as ... other workstreams' critical activities to enable facility startup and operational readiness.Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) ... documents; comfort engaging with regulatory authorities. Familiarity with Quality by Design (QbD) principles and their application in CMC development. Demonstrated… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic team at Formation Bio. ... revolutionize the drug development process, this role will center on the design , development, and deployment of advanced machine learning models, including those… more
- Formation Bio (New York, NY)
- …thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and unstructured data into ... strategy initiatives. AI Data Engineering & Unstructured Data Workflows Design and operationalize pipelines for classification, entity extraction, summarization, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR . Manager or Manager, Quality Management Systems (QMS). Title commensurate with ... (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to… more
- Merck & Co. (Rahway, NJ)
- …our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter-expert and advisor for our Autoinjector platform. This role's ... extensive knowledge in medical device engineering, particularly in the design , manufacturing, and regulatory aspects of Autoinjectors and combination… more
- Merck & Co. (Rahway, NJ)
- …to the Region. This includes continual optimization of the organizational - design and resources, ownership and optimization of key processes, talent and succession ... and - expectations. Participate and support the goals and objectives of the GCTO Senior Leadership - Team (SLT) or extended Leadership Team (eLT). Speak with "one… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies, prototype development, and advocate for scalable, compliant architecture and design .Collaborate with global quality, IT, and business leaders to align ... leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise in GxP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares… more
- Merck & Co. (Rahway, NJ)
- …Development Team (PDT) leaders and clinical directors responsible for the design and medical monitoring of clinical studies.Supervises development of clinical ... the pediatric section of the Vaccine Clinical Development TA.May serve as a senior therapeutic area content expert within the company, providing input into research… more
