The Senior Director is responsible for creating and implementing the system and infrastructure to support optimization, compliance and consistency of the Immunomedics Medical Affairs organization activities. This includes establishing standard operating procedures in compliance with federal and local regulatory requirements, developing an onboarding and training system, providing operational customer engagement support, establishing a procedure and technology tool for content development and maintenance, developing and implementing documentation systems, providing quality oversight and corrective action plans for Medical Affairs activities, and reporting on metrics for the field-based medical team, medical information, post-marketing research, and scientific communications. The Senior Director develops and executes innovative, integrated, scalable, and cost-effective solutions, utilizing state-of-the-art technologies and best-in-class processes, aligned with corporate goals, to optimize the functions and deliverables of Medical Affairs.

The Grants Coordinator ensures efficient execution of all administrative responsibilities of the Immunomedics Grant Program Committee (IGPC) including receipt and correspondence with grant applicants, management of the grants mailbox, development of the IGPC agenda, distribution of application materials for review to IGPC, documentation of all IGPC decisions, grant status tracking, letter of agreement administration and follow up, IGPC budget management and reconciliation, and grant closeout procedures. The Grant Coordinator will also provide administrative assistance to the Chief Medical Officer, the Vice President of Medical Affairs, Safety and Pharmacovigilance, and the Head of Regulatory Affairs.    

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.

Reporting to the Manager, Technical Investigation and Writing, the Principal Investigator will lead investigations related to Biologics Manufacturing (i.e., Upstream and Downstream) to support clinical/commercial Biotechnology Products.  The Principal Investigator will also be responsible for working with manufacturing and QA teams to agree on appropriate CAPAs as needed. In addition, the Principal Investigator may revise or create Standard Operating Procedures, Protocols, Risk Assessments.

Director, CMC Regulatory Project Management, under direction of the Head of CMC Regulatory Affairs, will work effectively with product development teams to establish and manage timelines and deliverables in support of global CMC regulatory submissions, CMC development activities, and responses to health authorities. . 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, while actively contributing to the overall project team. In addition, this individual will serve as the primary regulatory liaison for external manufacturing organizations.

The Maintenance Mechanic will be responsible for helping to maintain the Immunomedics facility and the various equipment and systems that enable us to operate. Emphasis on Boiler and auxiliary subsystems.   **This position is a second shift working (4x10) hour days from Wednesday through Saturday.** **A valid NJ black Seal High Pressure Boiler License is required**

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

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 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.

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.

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. 

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.