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The Quality Assurance Specialist focuses on the Product Disposition function, encompassing the review of production batch records and associated documentation required to release a production lot. This individual manages the batch documentation package and maintains records. This position may also be cross-trained for Raw Material Disposition, Clinical Shipments support and to provide oversight to operations on the manufacturing shop floor.
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Perform operational accounting responsibilities, including preparing journal entries, performing balance sheet reconciliations, assisting in the monthly closing process, and other accounting functions in support of monthly closing and financial reporting
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The Director/ Senior Medical Director Oncology within the Clinical Development Department is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. Strategic responsibilities include design and execution of clinical development plans for oncology products from preclinical research, First in Man studies through Phase I/II/III Clinical Trials.
The incumbent will successfully lead clinical trials Phase I - III, develop and author the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) and provide expert clinical oncology input and review of the study data as well as lead publication of documents required. S(he) will provide medical oversight of all studies within their program as well as leadership of clinical study teams. S(he) will work closely with a clinical scientist to provide support for development of the program including preparation of briefing documents, supportive materials necessary to progress strategic development and discussion of the program internally and externally.
S(he) will be responsible for representing the company and its development program and the respective trials when engaging KOL’s or other leaders in the field.
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Immunomedics is seeking a strong leader with experience in monoclonal antibody and/or antibody drug conjugate manufacturing. The candidate must have knowledge of mammalian cell culture and large scale protein purification. Candidate must have a working knowledge of cGMPs
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The QC Associate Scientist, Raw Materials, is responsible for routine testing of incoming raw materials for release and adventitious virus safety testing of bioreactor harvests, both inhouse and at third party provider. This position includes responsibility for validation and technical transfer of test methods, including the preparation of validation protocols and reports, authoring technical reports, specifications for incoming raw materials and evaluation of change notifications.
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The primary purpose of this second shift position is to provide support to the sample management group in a QC laboratory setting in support of commercial manufacturing. Responsibilities of the QC Sample Coordination Technician include collating receipt of samples and coordination of testing, preparation of samples using aseptic technique, organizing and tracking lot release data, submission of samples to contract testing laboratories and tracking sample custody. Activities include equipment maintenance, coordinating with Shipping and Receiving, and receipt of test results from contract laboratories.
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The Manager Procurement will be responsible for supporting the needs of our Morris Plains sites related to Supply Chain and Manufacturing. This individual will evaluate inventory and demand, create requisitions, generate purchase orders, track orders, and ensure timely delivery of requirements. This individual will be point of contact for Direct/GMP Material Vendors and answer questions and provide them with additional order documentation as needed. The successful candidate for this position will have experience in the Pharmaceutical/BioChemical Manufacturing industry and a strong understanding of Regulations related to cGMP Supply Chain management concepts.
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Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time. The position will also archive and track regulatory correspondences, documents and submissions.
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Provide Quality leadership and oversight to batch record review team and related activities. Perform and lead Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required. This individual manages the batch documentation package and maintains records. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Willing to be proactive and to provide effective long-term solutions non-conformances observed.
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The Quality Management System Specialist executes daily activities and maintains focuses on the Change Control, CAPA and Risk Management systems. This position ensures compliance with established and approved quality systems.
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The Clinical Scientist will provide scientific leadership for development and oversight of clinical studies (including documentation and data review). The Clinical Scientist serves as a key clinical resource for the assets in the pipeline and will be assignment to support specific development projects.
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The Warehouse Material Management Supervisor (WMMS) bldg. 410 will be responsible for the management of the inventory of all GMP raw materials and components. WMMS has responsibility for managing the warehouse within a GMP process for Receiving, Picking, Delivery, and Reconciliation within the Great Plains ERP System. WMMS will also be responsible for the day to day operations and management of all staff responsible for material management within the warehouse maintaining a warehouse that meets all GMP standards as identified by departmental SOP’s.
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The Biostatistician works directly with the medical project team to provide input into and insure the appropriateness of the statistical analysis methods described in the clinical study protocol. S/he develops statistical analysis plans consistent with the clinical trial primary safety and efficacy end points. The Biostatistician reports to the Director of Biostatistics.
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Senior Manager, Regulatory Project Management, under direction of the Director of Regulatory Project Management, will work effectively with product development teams to establish and manage timelines and deliverables in support of global regulatory submissions, with a focus on CMC submissions. This individual will coordinate submissions using Veeva Vault RIM, establish submission timelines and track progress for submission deliverables, coordinate/ support cross-functional submission planning meetings, and collaborate closely with Regulatory Operations for submission execution.
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The Scientist, Upstream Process and Manufacturing Sciences is responsible for the development and operation of mammalian cell culture processes under cGLP conditions.
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Function in the analytical group of Process and Manufacturing Sciences to support process and product development and characterization.
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Responsible for leading the Analytical Methods development and analytical characterization of commercial and clinical products.
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The Engineering Systems Coordinator will be responsible for administering the Engineering and Maintenance compliance systems to include: Work Order generation / planning and delegation, Environmental Monitoring System / Building Monitoring System.
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We are seeking a Principal Statistical Programmer to provide statistical programming and analytic support clinical studies.
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We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Oncology Sales Specialist, is a key position within the Immunomedics commercial team. The position will report to the Regional Business Director.