- Merck & Co. (Rahway, NJ)
- …immensely creative and collaborative team of scientists and engineers to design purification processes while developing technical strategies related to continuous ... integrated purification steps Expertise in independently conducting and directing the design , execution, analysis, and documentation of all stages of downstream… more
- Merck & Co. (Rahway, NJ)
- …will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early ... design concept definition through commercialization to support regulatory filing,...for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products.… more
- Merck & Co. (Rahway, NJ)
- …This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and ... design control and risk management techniques to positively support...Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution… more
- Merck & Co. (Rahway, NJ)
- …from late-stage preclinical work through clinical proof-of-concept studies. Translational study design : Design , oversee, and interpret PET imaging studies ... animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection. Regulatory support : Familiarity with… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist is a DVM and/or PhD whose primary function is to design , coordinate, monitor, and report clinical laboratory and field studies that will support ... Integrity - Precision - Accomplishment - Motivational Ambition - Respect - Inclusion. Design and organization of paper and Electronic Data Capture (EDC) clinical… more
- Merck & Co. (Rahway, NJ)
- …appropriate disease indications to pursue and subsequent study design , initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, ... development strategies for investigational drugs and planning clinical trials ( design , operational plans, settings) based on these clinical development… more
- Merck & Co. (Rahway, NJ)
- …identifies and anticipates technical or other potential problems arising in the design , conduct, and analysis of clinical trials, proposes solutions and carries them ... at advisory committee meetingsProvides responses to queries relating to study design , analysis, and interpretation posed by the clinical monitors, regulatory… more
- Merck & Co. (Rahway, NJ)
- …appropriate disease indications to pursue and subsequent study design , initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, ... development strategies for investigational drugs and planning clinical trials ( design , operational plans, settings) based on these clinical development… more
- Merck & Co. (Rahway, NJ)
- …to extract impactful insights from experimental data for manufacturing process design ;- employing process models to accelerate and enhance laboratory development ... through ML-assisted optimal experiment design ; applying physics-based and hybrid models to guide and de-risk scale-up/scale-down during technology transfer and… more
- Merck & Co. (Rahway, NJ)
- …technical writing and project management capabilities.Preferred experience in packaging design and thermal protection systems, particularly in qualification of ... Product Introduction Process, Packaging Engineering, Process Optimization, Product Packaging Design , Project Leadership, Risk Management, Root Cause Analysis (RCA),… more
- Merck & Co. (Rahway, NJ)
- …clinical development and studies, including development strategy, study design , initiation, execution, monitoring, analysis, regulatory reporting, and ... strategies for investigational or marketed Atherosclerosis drugsPlanning clinical trials ( design , operational plans, settings) based on these clinical development… more
- Merck & Co. (Rahway, NJ)
- …figures) for early oncology studies. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups ... quality Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis… more
- Merck & Co. (Rahway, NJ)
- …immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to ... challenges in the fieldExpertise in independently conducting and directing the design , execution, analysis, and documentation of all stages of cell-culture process… more
- Merck & Co. (Rahway, NJ)
- …/ amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment with the protocol in collaboration ... trials.Required Skills: Adaptability, Clinical Data, Clinical Operations, Clinical Study Design , Clinical Trial Compliance, Clinical Trial Management, Communication, Data… more
- ValSource, Inc. (Rahway, NJ)
- …SOPs. Field Verifications and system walkdowns to confirm systems meet design and client specifications. Regulatory Compliance: Ensure compliance with all relevant ... on multiple projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired. Experience… more
- Merck & Co. (Rahway, NJ)
- …possess deep technical expertise, a strong track record in problem-solving, experimental design and execution, along with leadership skills to shape the technical ... staff, fostering a culture of continuous improvement.-Deliver the development, design , construction, qualification/ validation and/or initial operation of complex… more
- Merck & Co. (Rahway, NJ)
- …and technology transfers across the network. Deliver the development, design , construction, qualification/ validation and/or initial operation of complex tertiary ... Subject matter expertise in development and qualification of package design and/or distribution/ transportation technologies for pharmaceutical products including… more
- Merck & Co. (Rahway, NJ)
- …for both inline and new products, guiding projects from early design concept through commercialization and post-market evaluation.Develop and execute the device ... and communicate effectively with cross-functional stakeholders and external suppliers.Support Design Transfer activities to internal and external sites ensuring… more
- Merck & Co. (Rahway, NJ)
- …of experiments for the adoption and development of innovative technologies.Lead the design and execution of bench scale process development experiments to meet ... Preferred Experience and Skills: Knowledge in bioreactor and process in-silico design / modeling.Familiarity with drug development cycle, especially the CMC… more
- Merck & Co. (Rahway, NJ)
- …and implementing them in the GMP areasSupport capital projects, work to design , install, and qualify new equipment to support GMP clinical production. Write, ... Manufacturing Processes, Microbiology, New Product Development, Pharmaceutical Sciences, Process Design , Process Hazard Analysis (PHA), Process Optimization, Proper Documentation,… more
