- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide front line ... the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...Quality team based in Raritan, NJ. Role OverviewThe QA Manufacturing Excellence Manager role is an exempt level position… more
- Insmed Incorporated (San Diego, CA)
- …associates for clinical and commercial production. May represent Insmed Gene Therapy as subject matter expert during external and internal regulatory ... viral vector gene therapies to market. Supporting our external manufacturing partners, you will be the process and data... partners, you will be the process and data expert and work to further improve the process of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … manufacturing science, analytical development, and familiarity with GMP/FDA/ICH .Key Responsibilities Subject matter expert of QC analytical methods in ... multiple myeloma.Legend Biotech is seeking a QC Analytical Methods Expert (Consultant) as part of the Global MSAT team...integrates with eLIMS and MES to manage samples from manufacturing in cGMP through final testing results. The scope… more
- Merck & Co. (Rahway, NJ)
- …build individuals and teamsRecognized as a subject matter expert in multiple drug delivery and/or manufacturing technologyDemonstrated ability to ... across functional areas to lead the development of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug… more
- Merck & Co. (Durham, NC)
- …ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert during tours to provide area/process overview information ... selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve...efforts and solutions offered by other shifts and teamsSubject Matter expert for LOTO and permit writing… more
- Aequor (Providence, RI)
- …vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies ... by collaborating with diverse functional areas including Supply Chain, Manufacturing , Quality Control, Regulatory, Quality Assurance, Quality Engineering, International… more
- Merck & Co. (Rahway, NJ)
- …contribute and lead.Track-record of independent problem-solving.Applying microbiology expertise as a subject matter expert for quality controlInteracting ... alternate microbial methods in a GMP environmentKnowledge and experience with manufacturing and GMP product testingExperience in leading and supporting quality… more
- Merck & Co. (Rahway, NJ)
- …and chemistry across high-throughput screening, hit-to-lead and/or lead optimization discovery space. Subject matter expert in biochemical & cell-based high ... accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12)… more
- Merck & Co. (Lower Gwynedd, PA)
- …supporting pre-clinical and clinical studies. The successful candidate will also serve as a subject matter expert , providing technical support as needed to ... regulatory authorities pertaining to bioanalytical strategy and execution.Serve as an internal subject matter expert on developed assays, providing technical… more
- Merck & Co. (Philadelphia, PA)
- …Third Party Due Diligence program. This predominantly includes being a process Subject Matter Expert (SME), leading system administration, answering ... Skills:5 years of experience in Procurement, Compliance, Quality, Technology, Manufacturing /Operations, Supply Chain or related Business OperationsExcellent communication skills… more
- Merck & Co. (Rahway, NJ)
- …to join our team. The individual in this role will provide subject matter expertise in cloud security engineering fundamentals supporting multi-cloud ... teams on Infrastructure as Code, Automation, and Orchestration. Provide expert knowledge of cloud and data security architecture and...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (North Wales, PA)
- …launch milestones, including creation of market development and promotional campaigns Serve as subject matter expert for market understanding and customer ... accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …outbound shipments and general warehouse activities as needed.Key Responsibilities Serves as a subject matter expert for inventory management and warehouse ... individual will work closely and collaboratively with Warehouse Operations, Manufacturing Operations, Finance, Scheduling, Planning and Procurement. In addition to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …liaison for the quality team in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group ... preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical… more
- Merck & Co. (Rahway, NJ)
- …final reports and publications summarizing data, and writing/updating lab SOPs.Serve as a subject matter expert in mass spectrometry-based assay development ... accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12)… more
- Merck & Co. (North Wales, PA)
- …profitable market access for a macrocyclic peptide drug. -The Director will be a subject matter expert on US health care ecosystem, interconnectivity of ... accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12)… more
- Novo Nordisk Inc. (Boulder, CO)
- …methods of oligonucleotide production, including template dependent and independent methods Be a subject matter expert in the use of enzyme classes ... RNAi therapeutics, continuing its legacy as the hub for all manufacturing -related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will serve as the point of contact for daily distribution of process materials, subject matter expert for operations inventory management and point of ... High School Diploma is required.A minimum of 2 years of experience within manufacturing and/or warehouse operations and logistics within a cGMP manufacturing … more
- Merck & Co. (Rahway, NJ)
- …cost/size, number of trials, clinical trial design and Go/No Go decisionsServe as a subject matter expert and foster collaboration within QP2 and across ... the above duties and to develop the above capabilitiesLeverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to end.Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.Serves as Subject Matter Expert (SME) in preparation for and during ... Operations group, process knowledge of the cell and gene therapy manufacturing , including but not limited to deviations (Quality Issues), investigations, CAPA… more
