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This position requires expertise in pharmaceutical drug development and manufacturing sectors, with strong emphasis in cGMP documents in compliance with FDA regulations 21CFR Parts 210, 211, and 610. In-depth experience in change control, investigation Quality Systems. familiar with analytical/bioassay stability laboratory test methods, instrument qualification, and method validation
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Immunomedics is actively recruiting for a Full Time Employee or Contract Permanent Sr. Clinical Scientist (CS), to provide scientific leadership for development and oversight of clinical studies. The CS is responsible for supporting assigned drug development projects specifically with clinical documents and data review. The CS serves as a key clinical resource for the assets in the pipeline.
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This position is responsible for providing leadership and direction for
GMP training programs and for ensuring compliance with all relevant FDA
and EU regulations and guidelines as they pertain to marketed drug
products. The Director, GMP Training has also responsibility to support
and identify any suspected deficiencies within the company’s Quality
Management System.
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Independently performs quality audits of sterile drug product manufacturers,
contractors and suppliers that support marketed drug products to ensure
products, controls, procedures and processes meet quality standards.
Prepares audit reports and communicates findings to external and internal
stakeholder. Able to act completely independently as a QA auditor.
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The Manager, Inventory Control evaluates and monitors inventory stock levels for all products in each area of the warehouse and manufacturing. This position is primarily responsible tracking and reconciling inventory usage and variances throughout the operations, completing cycle counts and regularly scheduled physical inventory counts for all locations utilizing company owned materials. The role ensures transactions within the system to support accurate and timely recording of material usage are timely and accurate. The position will ensure that inventory is allocated to the facilities to fulfill daily production demand.
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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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Responsible for maintaining site HVAC systems, Building Automation System, High Pressure Boilers and supporting systems for the Immunomedics manufacturing site. Operates within legal and regulatory compliance, ensuring systems are maintained and operational within site and regulatory requirements. Capable of following procedures, documenting work as/when performed through site work order system and maintaining a clean/organized workplace supporting site compliance and quality standards.
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The Clinical Nurse Educator is a key member of the commercial field team at Immunomedics. The Clinical Nurse Educator role provides product and disease state education and training to key healthcare providers within Oncology clinics and hospitals. The individual will work within a specified region to enhance disease knowledge, support the patient therapy selection process, coordinate and provide staff training, enhance proper administration, improve patient adherence and improve patient management. The individual will work in partnership with Immunomedics oncology sales team to help educate all health care providers, with a primary focus on nursing staff.
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The Clinical Nurse Educator is a key member of the commercial field team at Immunomedics. The Clinical Nurse Educator role provides product and disease state education and training to key healthcare providers within Oncology clinics and hospitals. The individual will work within a specified region to enhance disease knowledge, support the patient therapy selection process, coordinate and provide staff training, enhance proper administration, improve patient adherence and improve patient management. The individual will work in partnership with Immunomedics oncology sales team to help educate all health care providers, with a primary focus on nursing staff.
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The Clinical Nurse Educator is a key member of the commercial field team at Immunomedics. The Clinical Nurse Educator role provides product and disease state education and training to key healthcare providers within Oncology clinics and hospitals. The individual will work within a specified region to enhance disease knowledge, support the patient therapy selection process, coordinate and provide staff training, enhance proper administration, improve patient adherence and improve patient management. The individual will work in partnership with Immunomedics oncology sales team to help educate all health care providers, with a primary focus on nursing staff.
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The Clinical Nurse Educator is a key member of the commercial field team at Immunomedics. The Clinical Nurse Educator role provides product and disease state education and training to key healthcare providers within Oncology clinics and hospitals. The individual will work within a specified region to enhance disease knowledge, support the patient therapy selection process, coordinate and provide staff training, enhance proper administration, improve patient adherence and improve patient management. The individual will work in partnership with Immunomedics oncology sales team to help educate all health care providers, with a primary focus on nursing staff.
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The Clinical Nurse Educator is a key member of the commercial field team at Immunomedics. The Clinical Nurse Educator role provides product and disease state education and training to key healthcare providers within Oncology clinics and hospitals. The individual will work within a specified region to enhance disease knowledge, support the patient therapy selection process, coordinate and provide staff training, enhance proper administration, improve patient adherence and improve patient management. The individual will work in partnership with Immunomedics oncology sales team to help educate all health care providers, with a primary focus on nursing staff.
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This position requires a sound working knowledge of clinical data management processes and database systems within a multi-disciplinary team environment.
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The Director Downstream GMP is responsible for leading the downstream GMP manufacturing operations. The Director will serve as a subject matter expert and provide strong technical and organization leadership for the GMP manufacturing organization effectively supporting monoclonal antibody purification operations. The individual must manage manufacturing operations including but not limited to planning, GMP preparation, act as receiving and sending unit for technology transfer, and day-to-day operational decision making. The incumbent will work closely with a cross functional team of Process Development, Tech Transfer, Quality Assurance, Facilities, Engineering, and Project Management to ensure production operations are safe and right-first-time. The Director will adhere to all Safety and Quality standards of the organization and contribute to continuous improvement in the areas of Safety, Quality, Delivery, Cost, and People.
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We are seeking a Manufacturing Technologist I- Upsteam to be responsible for the manufacturing of clinical products in compliance with current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOPs).
Primary schedule will run Monday through Friday alternating between 6:00am-2:30pm and 10:00am-6:30pm, though occasional variation to those hours may be required.
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The QC Analyst performs product release and stability testing using capillary and gel-based electrophoresis methods, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.
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The core focus of the role is to support biomarker development and utilization for multiple exciting pipeline programs. This role will partner and work collaboratively with cross-functional team members to ensure alignment on project goals, milestones and deliverables.
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Immunomedics, Inc., a biotechnology company located in Morris Plains, NJ, is seeking a Validation Engineer to be responsible for the completion of assigned validation projects encompassing equipment, instruments, computers, cleaning, and process areas for entire validation life cycle.
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Immunomedics is seeking a Director of Validation to provide experienced, technical, and scientific leadership for process validation, equipment qualification, cleaning validation, technology transfer and process improvements at its Morris Plain, NJ site and at CMOs for monoclonal antibodies, fusion proteins, and antibody/protein biopolymer drug conjugates. Successful execution of this role requires a strong scientific and engineering approach, established expertise in upstream and/or downstream process development for therapeutic proteins, process characterization, process validation, and technology transfer experience. The ideal candidate has a track record of establishing mutual respect, trust, and close collaborations with internal and external organizations, and the ability to interact effectively at all levels. This position will report to the Vice President ofsmi Engineering.
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Develops and maintains short and long term production schedules. Supervises and manages activities of the group responsible for environmental control (sanitization) and materials preparation