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Associate Director, Supply Chain, Manufacturing/Quality Operations will work as a lead for critical Manufacturing and Quality projects.
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This position will be responsible for building and leading the project management office for Supply Chain, Manufacturing and Quality Operations. This individual will ensure successful execution of the overall Manufacturing & Quality strategy by coordinating and overseeing critical projects, including those with external partners. This position oversees several project managers / operations leads, assigning them to projects.
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Build and lead the Global Planning & Forecasting team within the Supply Chain organization to plan all aspects of our antibody drug conjugate production. The Global Planning & Forecasting team covers production planning and forecasting at our on-site manufacturing plant, all external manufacturing, as well as demand planning. This position will be responsible for leading a team of production planners and working cross-functionally with the Manufacturing and Quality leadership teams to ensure an optimal production schedule is developed and executed.
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The GMP Training Instructional Design Manager is responsible for the design and development of learning and practicing experiences. The goal is to facilitate learners in acquiring knowledge, skills and core competencies in an effective and appealing manner. Additionally, responsible for ensuring that the content developed ensures that employees are qualified and competent to perform their assigned job functions in accordance with regulatory requirements and IMMU Policies and Procedures.
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The Global Planning & Forecasting team covers production planning and forecasting at our on-site manufacturing plant, all external manufacturing. It is responsible for planning and forecasting all aspects of our antibody drug conjugate production. This position will be responsible for working cross-functionally with the Manufacturing and Quality teams to ensure an optimal production schedule is developed and executed, both short- and long-term.
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******This is shift position for 4/10-hour days Sun – Wed or Wed -Sat schedule
Manage a department of 1-3 analytical staff responsible for inspection, sampling and QC testing of biopharmaceutical utility samples, starting materials and raw materials. Support for raw material identity testing and other analytical methods are included.Leads Quality Control system activities such as support for demonstration of raw material testing, utility testing support, stability and retain management, investigations, method validation, method transfer, instrument qualification, corrective actions / preventive actions management, quality system monitoring, and creation of protocols and reports
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******This is shift position for 4/10-hour days Sun – Wed or Wed -Sat schedule
The QC Senior Analyst, Raw Materials, is responsible for routine sampling and testing of incoming raw materials for release both inhouse and at third party provider. The QC analyst is also responsible for routine testing of utility water and gas samples testing. The incumbent will be supporting testing and method validation activities either inhouse or at a third-party provider. The responsibilities may also include receiving, inspection and sampling of incoming raw materials as assigned by the management. This position also includes responsibility of authoring technical reports, and raw material specifications, as directed by the group manager
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Manages the subject area of Chemistry with respective instrumentation and methodology. This SME Manager role may be required to perform analytical testing. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness.
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Manages the subject area of Biochemistry.\biologics with respective instrumentation and methodology. This SME Manager role may be required to perform analytical testing. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness.
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The Director, Quality Control will be responsible for the strategic direction, management, and continuous improvement of cGMP Quality Control in the area of Chemistry and Cell Biochemsitry labs within Immunomedics. In this role, the incumbent will serve as the accountable business representative for Quality Control lab-related activities, including cross-functional partnerships and collaborations. The Director will manage a staff of mid-level managers, supervisors and/or individual lab personnel.
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The Senior Clinical Study Manager will be accountable for the overall management of assigned clinical studies and oversight of assigned clinical vendors.
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This position provides high quality engineering services to support the short and long
term needs of the company. Using project management tools and techniques, manages projects of medium to large scope ensuring that project goals, including budget, schedule, scope, quality, and risk, are met. Uses sophisticated analytical thought to exercise judgment and identify innovative solutions. Leads multiple highly-complex projects of diverse scope where analysis requires an understanding of current business trends. Fosters a productive team environment while driving projects to successful completion
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Medical Science Liaison (MSL) is a field-based representative of the Medical and Scientific Affairs Organization. The MSL is responsible for being a liaison to the medical and scientific community on behalf of Immunomedics. This includes identification and relationship building of Key Opinion Leaders (KOLs) and providing for meaningful scientific exchanges at national, regional and local levels in both academic and clinical practice settings. The MSL plays a critical role in introducing and managing Client’s presence in the oncology (breast cancer) space in the US initially in a prelaunch setting.
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Medical Science Liaison (MSL) is a field-based representative of the Medical and Scientific Affairs Organization. The MSL is responsible for being a liaison to the medical and scientific community on behalf of Immunomedics. This includes identification and relationship building of Key Opinion Leaders (KOLs) and providing for meaningful scientific exchanges at national, regional and local levels in both academic and clinical practice settings. The MSL plays a critical role in introducing and managing Client’s presence in the oncology (breast cancer) space in the US initially in a prelaunch setting.
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Supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external process and systems supporting Immunomedics clinical trials through commercial operations. Provides Drug Safety/PV compliance support to Clinical development and operations, including GVP QMS (quality manual, SOPs, WPs, etc.) development/maintenance. Actively contributes to the risk-based QA audit program, including CAPA, GVP training and inspection readiness. Provides day to day compliance support to Clinical study teams and cross-functionally to other functional areas, e.g., clinical supplies, Regulatory, Drug Safety/PV, medical affairs.
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Associate Director, CMC Regulatory Affairs will translate regulatory requirements working effectively with the respective process and manufacturing teams to collaborate, implement and interact meaningfully into workable strategies and plans for various stages of drug development of drug substance and drug product. This individual supports CMC regulatory filings for the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs.
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The Executive Director, US Marketing is a key leadership position within the Immunomedics commercial team. This person will be responsible for strategically leading a team of Marketers in preparation for the potential launch of sacituzumab govitecan in triple-negative breast cancer and other tumor types. The successful candidate will contribute in-depth oncology marketing expertise, work closely with internal stakeholders up to senior levels and external partners, with the capacity to develop a US marketing strategy and launch plan to support the brand.
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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.
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Role is responsible for strengthening the risk-based monitoring approach/practices and the applied oversight of our vendors. This highly specialized role, focused on monitoring excellence across the portfolio, will develop solutions to fuel a high-performing practice from study initiation through site closure. With a strong emphasis on inspection readiness and compliance, this leader will drive the relevant risk management framework and contribute to the internal education of personnel on the compliant management of monitoring in clinical trials globally.
The role requires regular contact with persons of influence and in decision-making positions within R&D and with CROs. As such, The Director of Monitoring Excellence requires strong oral and written communications expertise, and the ability to influence while obtaining desired outcomes in a goal-oriented environment. Ability to work independently and deliver results throughout the cross-functional network is critically important.