- Legend Biotech USA, Inc. (Raritan, NJ)
- …be willing to learn and be proficient in eLIMs, S4HANA (SAP) , MES ( Manufacturing Electronic Batch Record), and a Learning Management System. Electronic Batch ... Record), and a Learning Management System.Strong interpersonal skills and the ability to work well in a team environment is a must.Language: English#Li-Onsite#Li-DD1The anticipated base pay range is:$66,063—$86,706 USDBenefits:We are committed to creating a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …backup for approving printed labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work ... order to properly perform the assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based in ... Raritan, NJ. Role OverviewThe Director of Manufacturing Execution System (MES) will be part of ...MES solutions for the organization. This individual will ensure electronic batch records (EBRs) and associated log books, forms,… more
- Merck & Co. (Rahway, NJ)
- …multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New ... strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects.- Positions may… more
- Merck & Co. (Rahway, NJ)
- …colleagues while developing and expanding your career.The Executive Director, Chemistry, Manufacturing & Controls ( CMC) , Pre-approval Pharm will bring scientific ... (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing , and Global Human Health (GHH) divisions-to ensure these programs are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in ... Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in… more
- Merck & Co. (Rahway, NJ)
- …support release and stability testing of clinical materials. Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing ... of USP, EP, ICH, and FDA regulations. Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.- Experience with electronic … more
- Merck & Co. (Rahway, NJ)
- …products such as infrastructure, business applications, laboratory instrument systems, manufacturing automation systems and data analysis packages.Endorse and build ... areas focusing on business applications, laboratory instrument systems and manufacturing automation systems and related processes.As required, participate in 3rd… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a ... Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and reporting of relevant quality systems… more
- Aequor (Vacaville, CA)
- …Partners with internal and external stakeholders within Supply Chain, Manufacturing , Technology, Quality and Finance organizations to implement the production ... or project lead. Executes all work in accordance with Good Manufacturing Practice (GMP) standards, regulations, and documentation requirements. Prepares technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Associate MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role OverviewThe Associate MES Engineer ... will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for...IT. This individual will support the MES team with electronic batch record (EBR) updates and system improvements, support… more
- Merck & Co. (Rahway, NJ)
- …manage deliverables to progress the pipeline. - Responsibilities Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process ... - Preferred GMP experience is preferred. Experience with LIMS, SoftMax Pro, electronic notebook, or other data analytics platforms. Knowledge of assay validation… more
- Lundbeck (Bothell, WA)
- …cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to advance brain health and ... work and data, including capturing data accurately in appropriate electronic databases. Critical thinking, troubleshooting, and attention to detail. Excellent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the introduction of or revision process of existing SOPs in time to support Manufacturing Strategy.Ensure Master Batch Record changes are made in time to support ... Manufacturing Strategy.Ensure proper training is prescribed as per the...MS Office applications and other related IT Systems.Knowledgeable in electronic Document Repositories and LMS (Learning Management Systems)Ability to… more
- Merck & Co. (Philadelphia, PA)
- …Customer Satisfaction, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Leadership, ... Management Process, Manufacturing Quality Control, Organizational Performance Management, Quality Management, Regulatory Affairs Compliance, Regulatory Change… more
- Merck & Co. (Rahway, NJ)
- …methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit ... experience at the leadership level including the development of electronic submission deliverables.Designs and develops complex programming algorithms.Ability to… more
- Aequor (Cincinnati, OH)
- …Degree preferred Quality and/or food safety work experience in a manufacturing environment for 1-2 years. HACCP training Competencies/Behaviors: Demonstrated proven ... efficiently manage time. Ability to work in a food manufacturing environment. Ability to work a flexible schedule to...across all shifts Ability to become proficient user of electronic systems within the Quality function Ability to manage… more
- Merck & Co. (North Wales, PA)
- …methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit ... vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience assuring programming consistency across protocols and… more
- Merck & Co. (Rahway, NJ)
- …lists, scheduling lists, and tracking sheets- Archive PV documents (paper and electronic ) in accordance with procedures- Provide administrative support for PV tasks, ... daily in-person attendance is required for, field-based positions; facility-based, manufacturing -based, or research-based positions where the work to be performed… more
- Aequor (Thousand Oaks, CA)
- …to carry out high-throughput flow cytometry staining. Document experiments in the electronic lab notebook. Carry-out data analysis and communicate data to key ... biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by… more
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