- Merck & Co. (Rahway, NJ)
- …programs ranging from concept generation/selection through commercialization and launch readiness: Lead the Device Development Engineering Core team focused ... on development of design requirements for the combination product and engineering execution against the established requirements. Lead the cross-functional Device… more
- Merck & Co. (Rahway, NJ)
- …vendors.Drive and influence the technology and innovation strategic roadmap for the clinical end to end data flow in partnership with functional stakeholders, ... swim lanes and process maps to assist with the business process engineering and improvements.Create satisfying and compelling experiences for users working with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSolPlatform Business Lead (Capability Lead ) in the Platform Team plays a crucial role in analyzing business requirements, facilitating ... ensuring the successful implementation of platform solutions. The Platform Business Lead will collaborate closely with the platform team, product managers,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... with the CSO Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites for GMP processing operations.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Investigations Lead has the responsibilities for providing quality oversight over...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position for an Engineer will be responsible for providing engineering support at the Rahway non-sterile operations within Our Company's Research ... Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering ).Non-sterile operations plays a crucial role in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , ... Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP models to… more
- Merck & Co. (North Wales, PA)
- …:Address operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide. Lead ... support of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations. Lead and actively contribute to departmental strategic… more
- Merck & Co. (Rahway, NJ)
- …responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering , Automation Lead position and will be a member of the ... Job DescriptionDescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated… more
- Merck & Co. (Rahway, NJ)
- …PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and ... Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... a team-based environment, on an assigned production shift schedule. Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New ... Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for leading and facilitating Risk Assessment Projects to the cGMP Clinical and Commercial Cell Therapy Manufacturing Plant. In addition, the candidate ... with milestones and deliverables in collaboration with stakeholders (Quality, production, engineering , QC and process improvement and R&D etc.); conducting risk… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. If you're passionate about ... and manufacturing, to drive the successful translation of preclinical findings into clinical applications. Your expertise will be critical in advancing our mission… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... health technologies.Serve as the subject matter expert and independent project lead responsible for overseeing all aspects of project initiation, implementation, and… more
- Catalent (Manassas, VA)
- …to Regulatory Affairs and regulatory compliance. Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure compliance with ... Other duties as assigned The Candidate: Bachelor's degree in Chemistry, Biology, Engineering or equivalent, required 8 + years within the Pharmaceutical or related… more
- Merck & Co. (Rahway, NJ)
- …achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of the established ... enable visibility across regions and sub-functionsPartner with the Process Excellence Lead and others to identify process improvements based on insights gathered;… more
