- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... division and IT, including scientists, engineers, IT architects, infrastructure, quality , vendors in building, optimizing, and troubleshooting the OT automation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... and external cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (Rahway, NJ)
- …(mAb), antibody-drug conjugates, and fusion proteins.Strong grasp of Critical Quality Attributes/QbD/DOE principles and statistical data analysis ... will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform ... around rare diseases and immune disorders. Summary The Manager, Data Programmer is a member of the Biostatistics and...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… more
- Merck & Co. (Rahway, NJ)
- …transport, chemical/biochemical reaction kinetics, etc. applicable to biologics and vaccines), data driven models, and other modeling methods. Your experience should ... reduced costs, fewer experiments and batches, faster timelines, improved quality and process robustness.-Demonstrate creativity in solving complex, physical/biochemical… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... of small molecule, peptides and biologic modalitiesReview and approval of data and technical documents including critical evaluation of predictive modelsAbility to… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API) ... mentor junior staff within the CCT organization, and (iii) lead or support internal and external development with line...small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) / Quality by Design… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive innovation in product stewardship.- As a key senior… more
- Merck & Co. (Rahway, NJ)
- …development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will ... and Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the ... or participating in IH sampling activities for new or existing equipment.Support data rich experimentation at pilot scale via process analytical technologies (PAT)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and consistency within and across programs on an ongoing basis to ensure data quality and adherence to established coding conventions. In collaboration with ... resultant coded data . Proactively identifies potential risks to medical coding quality , integrity, and timelines for assigned studies and escalates issues to the… more
