- Eisai, Inc (Nutley, NJ)
- …and implement strategic vision and hands-on operational management strategies to expedite clinical operations activities.Ensure the timely, quality , and ... operations activities. These activities directly impact the timeliness, quality , and successful execution of clinical studies... Operations staff to oversee all aspects of clinical trial development. Lead clinical study… more
- Merck & Co. (Rahway, NJ)
- …( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development... supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
- Merck & Co. (Rahway, NJ)
- …/scientific execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical ... Material(s):n/aRequired Skills:Adaptability, Adaptability, Biological Sciences, Clinical Data, Clinical Data Interpretation, Clinical Operations , … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates ... your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of ...reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw ... process development, and seamless technology transfer to commercial sites.The SSO Operations Specialist will provide hands on assistance for daily production… more
- Eisai, Inc (Exton, PA)
- …profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team ... new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: - Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw ... development, and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Supervisor as part of the Technical Operations team based in… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations , Non- clinical , Clinical , and ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).- Education Minimum Requirements:- Bachelor's degree ... License:Hazardous Material(s):Required Skills:Applied Engineering, Applied Engineering, Chemical Engineering, Chemistry, Clinical Operations , Customer-Focused, Data-Driven Decision Making, Drug… more
- Merck & Co. (Rahway, NJ)
- …leadership to drive preparedness for agile and efficient multi-product manufacturing operations .Establish and lead a cross-functional launch readiness governance ... Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for manufacturing and...launch manufacturing.To achieve this, this highly experienced leader will lead cross-functional launch readiness teams at each site, drive… more
- Merck & Co. (Durham, NC)
- …responsible for the development, management, and growth of our warehousing and logistics operations , both on the main campus as well as off-site (3rd party) storage ... or supporting strategic projects designed to improve overall warehouse operations and efficiency.- Additional responsibilities will include qualification support of… more
- Aequor (Thousand Oaks, CA)
- …leadership experience Understanding of Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change ... Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems,...vital to the impact that ATO B20 with a clinical and commercial product mix has to the network.… more
- Merck & Co. (San Francisco, CA)
- …DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline ... execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewTechnical Trainer will be responsible for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell ... will partner with Training team members in collaboration with management in Operations to support personalized cell therapy production through safe and compliant … more
- Formation Bio (New York, NY)
- … efforts to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... and graph databases to power retrieval, enrichment, and relationship modeling. Platform Operations & Infrastructure Lead architectural decisions across the data… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …hazardous chemicals Ability to interact with all levels within the organization - Operations , Quality , HSE, Supply Chain, Warehouse, Training, QC, EM, ... Biotech is seeking a Metrology Technician I/II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for… more
- Insmed Incorporated (San Diego, CA)
- …supporting clinical GMP drug substance and drug product production and quality control operations . This role combines technical leadership in equipment ... and calibration standards. The individual will collaborate closely with the technical operations and quality teams to develop and implement robust calibration… more
