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The Vice President, Global Information Technology (IT) is responsible for setting the enterprise IT strategy and driving cross-functional IT needs by being well versed with industry trends and emerging technologies. S/he must continuously envision how to transform the business through technology. S/he will be responsible for overseeing technology professionals accountable for global IT infrastructure and support. S/he provides a strong leadership role model and creates an environment that promotes professional development and growth. The ideal candidate will balance the technical aspects of this position and the ability to integrate the company’s corporate strategy with IT priorities. S/he possesses excellent communication skills to provide clear and business focused (non-technical) communication to senior management.
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The QC Analyst performs routine product release and stability testing using HPLC and UPLC, 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 QC Senior Analyst performs routine product release and stability testing using gel based and capillary 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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Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, and other GMP processes as required. 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.
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Ensure the deviation process meets Industry and Immunomedics expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained. Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. Performs CAPA effectiveness checks as required. Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. Initiates Escalation activities as required. Participate in escalation meetings as required. Performs trending analysis of deviations, CAPAs, OOS as required. Supports APQR program with regards to providing analysis for deviations and CAPAs. Supports the preparation and presentation of trend reports for Quality Management Reviews. Implements and ensures adherence of appropriate regulations and Immunomedics quality standards.
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The Maintenance Supervisor will be responsible for all maintenance activities of the facilities, utilities and equipment required to allow Immunomedics to operate effectively.
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The Maintenance Manager will be responsible for all maintenance and calibration activities of the facilities, utilities and equipment required to allow Immunomedics to operate effectively.
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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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The Warehouse Supervisor leads a team with responsibility for all warehouse operations (receiving, storage, materials delivery to production and shipping) are executed on time and in strict compliance with GMP, EHS and Quality Systems. This position is responsible for supervising and assisting warehouse personnel and ensuring a safe operation of the warehouse. Routine responsibilities include people management, establishing workload priorities, in addition to ensuring an accurate materials inventory.
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We are seeking a Pharmaceutical Manufacturing Technologist I 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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Responsible for providing support to manufacturing to maintain the environment through the cleaning, sanitizing and disinfecting clean rooms and equipment as well as preparing needed materials for use in both the upstream and downstream manufacturing areas.
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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
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Lead and manage the company’s transaction services (i.e. A/P, Payroll, T&E)
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The Quality Control Manager, Stability will be responsible the stability programs for all clinical and commercial biologic process intermediates, drug substances and drug products across internal and external manufacturing sites. The manager is responsible for the Immunomedics’ global product stability strategy and manages internal logistical and technical operations for QC that includes site sample management.
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Ensure the deviation process meets Industry and Immunomedics expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained. Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. Performs CAPA effectiveness checks as required. Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. Initiates Escalation activities as required. Participate in escalation meetings as required. Performs trending analysis of deviations, CAPAs, OOS as required. Supports APQR program with regards to providing analysis for deviations and CAPAs. Supports the preparation and presentation of trend reports for Quality Management Reviews. Implements and ensures adherence of appropriate regulations and Immunomedics quality standards.
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We are seeking a Microbiologist to be responsible for performing microbiological testing of cGMP controlled areas, pharmaceutical grade water, and in-process materials in compliance with cGMP guidelines and SOPs.
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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 Sales Administration Manager, is a key position within the Immunomedics commercial team.
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The purpose of the Senior Category Manager role is to:
1) Develop category strategies for the assigned categories.
2) Plan and execute the sourcing process for all relevant central activities.
3) Execute and adhere to Corporate Sourcing strategy, policy, systems, and processes.
The Senior Manager, Clinical and R&D Procurement will actively support the development and implementation of strategies for the Immunomedics clinical services sourcing categories. In doing so, the Sr. Manager, Clinical and R&D Procurement works closely with Immunomedics Global Brands (including Clinical Development, Clinical Operations, and the Chief Medical Officer organizations), Finance, and Global Procurement teams to ensure these strategies and their related implementation plans are managed proactively and through cross-functional teams. In this role he/she will be part of a team dedicated to developing and deploying category strategies for a range of clinical/pre-clinical services
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The purpose of the Senior Manager role is to:
1) Develop category strategies for the assigned categories.
2) Plan and execute the sourcing process for all relevant activities.
3) Execute and adhere to Corporate Procurement strategy, policy, systems, and processes.
The Senior Manager, Manufacturing/Technical Operations Procurement will work within multi-disciplinary team and assume responsibility for leading the development and execution of Supply Chain sourcing strategies to leverage relationships with suppliers, global affiliates and CMO partners to gain competitive advantage. This includes supplier relationship management, negotiation, risk management, supplier performance management. Strengthens and develops relationships with key partner organizations.
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