- 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)
- …designs, regulatory submission documents, etc.Perform investigations with strong technical troubleshooting skills.Provide documentation / technical input ... DescriptionOur company is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical… 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)
- …scales. Serving as a steward for scientific excellence, the Crystallization Lab Lead advocates technical growth opportunities through collaboration with internal ... is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative) such as clinical development,… 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)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... development.Responsibilities include, but are not limited to:Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy,… more
- Merck & Co. (Rahway, NJ)
- …and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...collaboration is expected. Experience in leading small groups of technical personnel, leading projects, and defining group or departmental… more
- Merck & Co. (Rahway, NJ)
- …-group in Rahway, NJ is seeking a motivated scientist with technical expertise in mass spectrometry-based protein characterization. This position has the ... group in project teams.Author regulatory submission sections and responses, technical reports and scientific presentations.Explore and develop new technologies to… 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)
- …include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure ... agency background packages, post-approval submissions/variations, 510(K)s, CE markings. - Lead the development, communication, and review of Regulatory Strategies… more
- Merck & Co. (Rahway, NJ)
- …Accounting, this role is integral to our financial management team.Key Responsibilities: Lead the monthly financial close process by preparing and reviewing ... Sheet, Income Statement, Cash Flow statement, and other financial documentation .Collaborate closely with both domestic and international subsidiaries to advise… 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… 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
- 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
