- Merck & Co. (Rahway, NJ)
- …company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the ... external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of… more
- Merck & Co. (Rahway, NJ)
- …project teams.Proven track record of applying analytical skills in product design , development, and validation.-Proven ability to lead team members ... extensively with subject-matter experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly… more
- Repligen (Hopkinton, IA)
- OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager and helps in performing all tasks involved in the production of Repligen's fluid ... as kitting of parts, cutting of tubing and polymer film, reading design drawings, performing basic and complex assembly techniques, executing detailed visual… 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, ... and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository. Design and implement the architecture for a scalable data hub, using cloud… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design ... Sterile Product Development & Commercialization (SDPC, our Manufacturing Division) in the design of new formulations and development of robust and scalable processes… more
- Merck & Co. (North Wales, PA)
- …candidate should have a solid knowledge of statistical methodology, experimental design , computing software and data management; a general understanding of worldwide ... trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development… more
- Merck & Co. (Rahway, NJ)
- …on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... 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
- Twist BioScience (South San Francisco, CA)
- …documentation, specifically tailored for custom software.Electronic Batch Record (EBR) Management: Lead the design , development, and continuous improvement of ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Genmab (NJ)
- …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Merck & Co. (Rahway, NJ)
- …mRNA display screening, virtual screening, screening hit identification, lead optimization, modality drug design , high-throughput experimentation.Experience ... capabilities in structure-based modeling, predictive science, and AI/ML to drive drug design and development globally, with a proven track record of pipeline impact.… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …medicines for patients.Key Responsibilities Be able to work independently under minimal supervision. Lead , design and optimize research with aims of exploring ... a Scientist as part of the R&D Novel Car Design team based in Piscataway, NJ. Role OverviewWe are...in-vivo CAR virus using in-vitro assays and in-vivo mice models. Design , execute and interpret research requiring molecular biology techniques… more
- Aequor (MA)
- …technologies for the treatment of ocular disease., The successful candidate will: Lead research projects to support the identification of therapeutic candidates from ... to generate proof of concept data. Apply expertise to design , develop scientific activities/projects to identify therapeutic candidates. Demonstrate scientific… more
- Novo Nordisk Inc. (Durham, NC)
- …Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and ... with stakeholders Collaborate with cross-functional teams to support the design and building of data pipelines for cleaning, transforming,...sources (PCS, MES, SAP, PI Historian) Serve as a Lead and SME in supporting audits & inspections for… more
- Merck & Co. (Durham, NC)
- …and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support ... and business processes related to any new project implementations.Site supply chain lead and coordinator for the successful implementation of SAP S4/HANA targeted… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… 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 ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… 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 ... and potentially affect the companys ability to achieve its goals Lead collaborative interactions among market researchers to ensure better practices sharing… more
- Eisai, Inc (Nutley, NJ)
- …want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the ... a key opportunity for a talented, passionate marketer to lead important and innovative commercial work streams for a...Patient Support, and our Specialty Pharmacy partners in the design and delivery of this solution.Partner in the ongoing… more
