- Eisai, Inc (Boston, MA)
- …of contact between Eisai and formulary decision-makers within identified Health Systems representing Eisai's product portfolio.The Health System Account ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system … more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies .… more
- Merck & Co. (Rahway, NJ)
- …is preferred):BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 20 ... development.MS/ MA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Twist BioScience (South San Francisco, CA)
- …RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San ... product lines and deep understanding of integration to eCommerce and ERP systems to ensure scalable, robust, and flexible cross-functional solutions that support our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Merck & Co. (Rahway, NJ)
- …assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report ... and clinical customer relationship management.-Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... or finished pharmaceutical environmentExperience in automation and manufacturing execution systems (MES), process modeling and process improvement.Mechanical functionality and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe...define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data… more
- Eisai, Inc (San Jose, CA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... pathway).Engage and influence key customers (including local and regional hospital systems ) to sustain a strong organizational presence in the Alzheimer's… more
- Eisai, Inc (Indianapolis, IN)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Management Assess and adapt sales and promotion strategies to align with health system account practices, care pathway decisions and managed care impact in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing security… more
