The Vice President, External Manufacturing will have accountability for the operational oversight of all external nodes of the global supply chain.

Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP)

This position will be responsible for formatting and publishing electronic documents and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time.  This position will also archive and track regulatory correspondences, documents and submissions.

The Associate Scientist, Upstream Process and Manufacturing Sciences is responsible for the development and operation of mammalian cell culture processes under cGLP conditions.

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.

The Microbiologist I will be responsible for performing microbiological testing of cGMP controlled areas, pharmaceutical grade water, and in-process materials in compliance with cGMP guidelines and SOPs.

The QA Ops Manager manages the Immunomedics Product Disposition Team.  Continually evaluates disposition priorities and recommends system improvements. This position also includes direct responsibility for Product Disposition, encompassing the review of Production Batch Records and associated documentation required to release a Production lot.  This individual manages the Batch Documentation package, conducting follow-up/ investigations when required and maintaining records in QA. This individual also participates in audits, investigations, SOP preparation, CAPA’s and other projects as appropriate.

This position provides project management support for Process Sciences and External Manufacturing departments. Develop specific project plans and timelines, monitor progress and develop reporting tools to provide management and team updates on progress/risks and planning. Responsible for document tracking, uploading and tracking reports in Quality management System, assisting with change control deliverables.

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 develops and implements CMC regulatory strategies with the CMC RA team to support the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs in the context of submissions to, and communications with, the Health Authorities while actively contributing as a key member of the project team.

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 develops and implements CMC regulatory strategies with the CMC RA team to support the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs in the context of submissions to, and communications with, the Health Authorities while actively contributing as a key member of the project team.

This position will provide scientific leadership for development and oversight of clinical studies. This individual will be responsible for supporting assigned drug development projects specifically with clinical documents and data review. This position serves as a key clinical resource for the assets in the pipeline.

Manage the lifecycle of contract manufacturing activities for commercial or clinical products at one or more conjugation and drug product third party manufacturing organizations (CMO), including CMO selection, process technology transfer, routine cGMP manufacturing. Establish and maintain alignment between CMO site business, operations and quality objectives and plans and Immunomedics commercial/clinical manufacturing strategies and plans. Establish and manage business operations, and quality relationships and communications between Immunomedics and the CMO as the lead point of contact for Immunomedics. Build and lead cross functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operations and quality objectives, plans and performance goals. Provide the single point of accountability for identifying and managing timely resolutions of business, operational and quality issues through established CMO site governance structure. Provide strategy planning for scaleup and second source activities to enhance the global supply chain.

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.

The Supervisor of Quality Assurance is responsible for coordinating and managing on the floor Quality Oversight, during second (2nd) shift Operations, to ensure sustained compliance with GMPs and regulatory readiness.

The Regional Director, Medical Science Liaisons, will manage and provide leadership to a team of regional Medical Science Liaisons (MSLs) at Immunomedics. The primary responsibilities of this position are to help provide structure and guidance to the company’s field MSL team, and subsequently assist in the hiring and day to day oversight of MSLs within the respective regions. The Regional Director, Medical Science Liaisons will also be responsible for representing the Field Medical Affairs team, both internally and externally, as a clinical expert supporting potential product launches and ongoing pipeline development. This individual will report to the Senior Director, Medical Science Liaisons

The Senior Process/Automation Engineer, Manufacturing will be the technical resource providing support to portions of the manufacturing process with the goal of ensuring reliable performance and identifying opportunities for continuous improvement. 

Reporting to the Vice President, Global Head of Safety and Pharmacovigilance, the Senior Medical Director will be responsible for the oversight of medical safety functions for Immunomedics’ products, both those in clinical development and marketed products.  This global role involves both strategic and operational aspects. The Senior Medical Director will be responsible for the ongoing safety surveillance of Immunomedics’ products, including evaluation of safety data from all sources, signal detection, benefit-risk evaluation, and, development and implementation of risk management strategies, and cross-functional Safety Management and Global Benefit Risk Teams.  Additional responsibilities include oversight of medical safety functions performed by vendors, such as medical review of individual case safety reports, and oversight/authoring of safety sections of regulatory submissions, including periodic reports and marketing authorization applications.  This role will involve close collaboration with the Clinical Development teams, Regulatory Affairs, Medical Affairs, and Clinical Quality Assurance functions, and the Senior Director, Safety and Pharmacovigilance.  The Senior Medical Director will be a Subject Matter Expert for safety and pharmacovigilance issues related to Immunomedics’ products, other related products (both in development and marketed), and the indications under study.  Importantly, the Senior Medical Director will aid the Global Head in strategic planning for creating and implementing state-of-the-art processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities, and developing an organizational structure to support these activities.

The Project Manager works cross-functionally and collaboratively to support product development and life cycle management activities. This position will ensure consistent and effective project management leadership of global drug development project teams.

The Project Manager works cross-functionally and collaboratively to support product development and life cycle management activities. This position will ensure consistent and effective project management leadership of global drug development project teams.

Primary function in the Downstream Process group of Process and Manufacturing Sciences in development, optimization and characterization of antibody-drug-conjugate (ADC) conjugations. Participate in core Downstream Process development and activities for antibody purification. Interface with analytical team in development of ADC-specific analytical methods for characterization of clinical, commercial and new products.