- Merck & Co. (Rahway, NJ)
- …process commercialization.Experience in leadership of CMC development teams.Experience authoring technical documentation in support of the following: process ... the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the employees in the maintenance process, the information from SAP, the technical documentation and other data systems. With this information, the Asset ... technical works on the basis of an asset management system. You take the lead in new projects and also provide technical support for improvement projects of… more
- Merck & Co. (Rahway, NJ)
- …operations, process development activities, compliance investigations/change management, authoring of GMP documentation , and lead other staff in the pilot plant ... a fast-paced job that provides a high degree of technical and project management responsibility. - This SSO Process...plant. The Process Engineer position reports to a Facility Leader and the successful candidate will be an integral… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical and project management responsibility.-This SSO Process Engineer role within the SSO Pilot ... Plant leverages scientific, technical , and operational experience to support facility operations, process development activities, compliance investigations/change… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... and engineers to design upstream, cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and produce preliminary solution design and architectural diagrams. 35 E- Lead technical feasibility discussions, prototype development, and design efficient, ... research areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within… more
- Merck & Co. (Rahway, NJ)
- …mentoring.- This position leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process ... and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and self-initiative… more
- Merck & Co. (Rahway, NJ)
- …of scientists and engineers to design purification processes while developing technical strategies related to downstream processing for drug candidates in early- ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable purification processes for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analytics, testing, and integration, to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the ... creation of business cases and the preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage vendor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an advisor to North America ... of new and existing CMR employee on-boarding, cultural engagement, technical /role-specific training and GxP/Regulatory compliance across CMR functions. Position will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting the document ... the periodic review process for procedures, as needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to internal procedures for ... to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs...trial progress and bring deviations to the Operational program Lead and study team leader . Review and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a strong working knowledge of medical terminology concepts and industry standards and technical skills in coding data received from CROs and vendors. This position ... disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships This position reports to the Associate Director, Patient Insights LEAD . Other key relationships include interactions with Patient Support Services, ... enhance patient support services and drive strategic initiatives Program Optimization Lead the optimization of patient support programs by leveraging data insights… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, Quality Control, Information Technology, maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, ... and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to ensure accurate documentation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and policy ... areas for support requests and inquiries. The GSM has a strong technical background, excellent communication skills, is well organized, and an outstanding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Functions Leads the coordination and preparation of RE/AB budget support and documentation from draft protocol through trial closure for North America Clinical ... a variety of complex situations requiring new solutions Ability to influence, lead and effectively interface within a matrixed environment and with varying… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, ... requirement.Experience directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop and set… more
- Amazon (New York, NY)
- …into a better-rounded professional. TCX Engineering builds tools to deliver innovative technical documentation for AWS. We work directly with writers, editors, ... Maturity, impeccable judgment, and the ability to influence and lead are essential to success in this role. You...the work of multiple engineers. * Design and own technical architectures that are scalable, performant and easy to… more
