- Merck & Co. (Rahway, NJ)
- …People Management, Product Commercialization, Product Design , Product Development Design , Project Management, Prototyping, Regulatory Compliance {+ 4 ... teams to ensure needs of manufacturing are considered as part of the design . Provide information and drive early alignment and readiness reviews with manufacturing… more
- Merck & Co. (Rahway, NJ)
- …scaling up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing ... to drive resultsCan independently execute formulation and process development activities using Design of Experiment s for new chemical entities or life cycle… more
- Twist BioScience (South San Francisco, CA)
- …for our custom MES, including detailed requirements gathering, system design , coding standards, development, rigorous testing, validation, deployment, and ... Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS),… more
- Merck & Co. (Rahway, NJ)
- …and applies knowledge of informed consent medical writing responsibilities, including design , planning, writing, editing, and review of accurate, clear, high-quality ... a developing understanding of clinical development, study protocols (eg, design , objectives, and study procedures), relevant regulations, disease areas, and… more
- Merck & Co. (Rahway, NJ)
- …as assigned. Skills Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management ... identifying gaps in the QMS documents.Working knowledge for the design , manufacture, packaging, purchasing, testing, release, storage, and distribution of… more
- Merck & Co. (Durham, NC)
- …facility will include end-to-end processing of drug substances.As the team finishes the design and construction of the facility, the Operations Manager will play a ... have the unique opportunity to give input in the design process, startup their areas, and lead the teams...degree in a technical field AND at least four ( 4 ) years in a manufacturing, technical, support, or Military… more
- Repligen (Clifton Park, NY)
- …equipment.Programming - Ladder Logic, industrial ethernet systems, Industry 4 .0QualificationsWork EnvironmentThe Manufacturing Engineer will be required to perform ... will" employment relationship.Skills and Competencies Lean ManufacturingCAD (Computer Assisted Design ) Design of tools, fixtures, and equipmentMachining processes… more
- BioAgilytix (Durham, NC)
- …integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA. Design data quality KPIs and implement initial quality checks independently, ... core systems (LabVantage LIMS, ERP) into a centralized data repository. Design and implement the architecture for a scalable data...| Long Term Disability Life Insurance, Paid Time Off ( 4 weeks per year), Parental Leave, Paid Holidays (9… 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 ... in site management and selection decisions. Provide input into protocol - design , feasibility, and resource assessments as appropriate. Support the development and… more
- BioAgilytix (Durham, NC)
- …immunology, biotechnology, or related field with not less than four ( 4 ) years' experience in a scientific laboratory environmentMinimum Preferred Qualifications - ... teams Knowledge and application of regulatory guidance to experimental planning and design Experience working in GxP environments and demonstrated knowledge of GxP… more
- Merck & Co. (Rahway, NJ)
- …appropriate corrective and preventative actions.Directly contributes to experimental design , execution, and data interpretation for validation studies.Support ... a PhD degree graduating on or before Spring 2025; 4 years of experience with a MS degree, or...Process Analytical Technology (PAT), Product Lifecycle, Protein Analysis {+ 4 more}-Preferred Skills:Job Posting End Date:06/20/2025 *A job posting… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to/from other M2-US or NN teams Lead document control process across site Design & own process for implementation of new/revised documents (to include change ... experience supporting cGMP pharmaceutical manufacturing preferred Minimum of four ( 4 ) years of leadership &/or direct management responsibility experience required… more
- BioAgilytix (Durham, NC)
- …biochemistry, immunology, biotechnology, or related field with not less than four ( 4 ) years' experience in a scientific laboratory environment; orPhD in chemistry, ... teams Knowledge and application of regulatory guidance to experimental planning and design Experience working in GxP environments and demonstrated knowledge of GxP… more
- Merck & Co. (Durham, NC)
- …Device Components. Final Assembly and Packaging of Combination Products. Experience with OEB 4 / OEB 5 compounds is a plus. New Product Introductions - Knowledge ... a plus. Process Improvement - Knowledge of lean principles, equipment design , and preventative maintenance.- Regulatory - Global regulations and compliance… more
- Merck & Co. (South San Francisco, CA)
- …team strategy and lead the formation and execution of team-specific PDMB workflow. Design and execute in vitro and in vivo mechanistic and translational studies ... proteins, such as drug conjugates and other modalities, to influence drug design , lead selection, and drive PK/PD translations. Be accountable for providing timely… more
- Merck & Co. (Durham, NC)
- …with strong scientific and technical skills to contribute to the design , development and manufacturing of sterile products, making accessible our company's ... biochemistry, chemistry or related life science or engineering discipline. Minimum of 4 years (Doctorate), 6 years (Masters) or 8 years (Bachelors) experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? The Position The ... A Master of Business Administration (MBA) is preferred A minimum of 4 years managing markets analytics/research experience with a Bachelor's degree is required… 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 ... validation, and compliance in pharma/biotech/medical device industry - Required 4 + years of proven leadership experience managing technical and validation… more
- Eisai, Inc (Exton, PA)
- …capital budgets, and creates staffing plans based on prescribed organizational structures. 4 . Oversee the scale-up of new DS/ADI processes and technologies, working ... knowledge on industry best practices and emerging trends.8. Oversee design , implementation, and commissioning of new technologies for manufacturing. Oversight… more
- Merck & Co. (Rahway, NJ)
- …Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.Required Experience and Skills:Strong background and experience in ... in data analysis and familiar with using statistical software for design of experiments.Experience with qualification, validation, and transfer of assays to… more
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