We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The position is responsible for building relationships, account plans and executing strategies to improve patient access and drive company performance within key National Accounts (Payers, IDNs, large organized customers). The position is responsible for leading the matrix team in account planning and implementation, driving optimal access, and appropriate utilization of launch product in all assigned accounts. These include national payers, the largest oncology networks, pathway companies, and other oncology organized customers. Deep knowledge and understanding of the clinical, economic and business model dynamics driving decision making and coverage is critical. Deep understanding of the business of oncology and the clinical label and data for launch product and competition are essential. The National Account Director is responsible for developing strong access and business relationships and communicating approved clinical and economic data with key oncology decision makers and advisors within a variety of key accounts. Knowledge and understanding of oncology access influencers is also important. This includes groups like ASCO, ACCC, COA, NCCN, State Oncology Societies, etc. The National Account Director develops and ensures execution of the account business plans which include both strategic and financial objectives. The National Account Director is responsible for aligning the full matrix team to execute the plan. The position serves as the primary interface between Immunomedics and our national oncology customers. The position reports directly to the Director, Payers and Strategic Accounts.

The Senior Director, Upstream, Downstream Production, and Manufacturing Support is responsible for leading the three groups within Manufacturing to support of all GMP Manufacturing operations. The Senior Director will serve as a subject matter expert and provide strong technical and organization leadership for the GMP manufacturing organization effectively managing MAb operations and supporting all other GMP Manufacturing operations. This individual manages Manufacturing operations including but not limited to planning, GMP preparation, receiving technology transfer info, process and equipment optimization, and day-to-day operational decision making. The individual will work closely with a cross functional team of Process Development, Tech Transfer, Quality Assurance, Facilities, Plant Engineering, and Project Management to ensure all activities within Manufacturing operations are safe and right-first-time. The Senior 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.

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

This position will be Tuesday-Friday (0600-1630). Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP) 

This position will be responsible for managing packaging configurations and distribution strategies.

The Incumbent will be responsible for overseeing the Viral Safety testing and Viral clearance program at IMMUNOMEDICS for both commercial and pipeline products. Success in these areas will require strong technical/scientific and leadership skills, experience with all areas related to virology and the ability to project cross-functional influence in a GMP environment

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. 

Manages QC staff responsible for the day to day data review function of QC testing of biopharmaceutical product and intermediate, bulk drug substance and drug product, provides leadership and manages performance. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness. This Quality Control Data Review Manager is a subject matter expert on review of documentation associated with the operation of a cGMP QC laboratory. Responsibilities include the application of uniform practices for review of analytical raw data and electronic data in the analytical laboratory supporting batch release, stability, cleaning verification, raw materials release, method qualification and method transfer activities. Routine inspection of laboratory documentation for compliance with current industry standards is also within scope.

Ensures appropriate processing, revision and control of quality documents in the electronic DMS, monitors and responds to Document Control mailboxes, provides internal user/customers support by responding to questions and inquiries, training, and coordination of workflow activities throughout the document lifecycle.  Responsible for issuing, receiving and archiving of quality records processed through the QA Document Control Center.  Provides timely and accurate document support to all GMP functions at Immunomedics facility.

Responsible to define, maintain and oversee the IT strategy regarding adherence to applicable global regulatory requirements (i.e. 21 CFR Part 11, Annex 11). This position will provide partnership across the business (i.e. Manufacturing, Quality, Validation, Compliance, etc.) through quality management and quality oversight activities intended to ensure overall global regulatory adherence. This includes partnering with key business stakeholders in the development of the computer system validation corporate strategy, provide subject matter expertise and lead the IT component of the corporate wide CSV program. Provide CSV expertise while working closely with the validation and quality teams to deliver on key elements of the quality and compliance programs in support of business objectives. This position will have responsibility and ownership of all IT CSV related policies and procedures, including the CSV Master Plan, ensuring they meet organization needs and remain aligned to global regulatory guidance. This activity includes partnering with corporate training to ensure the organization is properly trained on CSV concepts, policies, processes and procedures.

The Director, Maintenance and Engineering will be responsible for overseeing the engineering change control process, preventive maintenance system, receipt of new equipment, calibration activities, Blue Mountain scheduling system, Site Security, EH&S oversight, Janitorial services, maintenance critical spare parts inventory and facilities related projects.

Responsible for the operation of mammalian cell culture production processes in compliance with current Good Manufacturing Practice (cGMP) regulations.

Reporting to the Associate Director, Quality Compliance, the Senior GMP Compliance Specialist will play a critical role in in ensuring a continuous and sustainable state GMP compliance, through internal audit, monitoring, and oversight of self-inspection programs.  This position will assist in ensuring all GMP personnel remain complaint with applicable regulatory requirements and Immunomedics policies and procedures, in support of Immunomedics clinical/commercial products.  This includes ensuring there is appropriate training and consistent data integrity and compliance.  

Reporting to the Associate Director, Quality Compliance, the Senior GMP Compliance Specialist will play a critical role in in ensuring a continuous and sustainable state GMP compliance, through internal audit, monitoring, and oversight of self-inspection programs.  This position will assist in ensuring all GMP personnel remain complaint with applicable regulatory requirements and Immunomedics policies and procedures, in support of Immunomedics clinical/commercial products.  This includes ensuring there is appropriate training and consistent data integrity and compliance.  

Responsible for providing global and FDA regulatory strategic guidance to clinical development teams with regard to regulatory requirements and health authority interactions. Support regulatory clinical study filings, leading and preparing teams in seeking Agency advice and maintaining compliance with reporting requirements such as DSUR, Orphan drug, PSP, annual reports, etc. Acts as Company Liaison for Health Authority interactions.

Responsible for providing support to manufacturing to maintain the production environment through the cleaning, sanitizing and disinfecting of clean rooms and equipment as well as preparing needed materials for use in both the upstream and downstream manufacturing areas. This would be 1st shift Wed-Sat. 

AD/Director, Sales Training is responsible for developing and leading a comprehensive sales training program in preparation for the launch of Sacituzumab Govitecan. This role is responsible for the development and delivery of product and clinical training curriculum and assessments as well as confirming Oncology Account Managers and Regional Business Directors are effectively trained on relevant selling skills that reflect the needs in the current market environment. This individual will work closely with product teams to develop and execute a sales training strategy that promotes brand and company goals. As an in-house expert on training and adult-learning, this person will provide guidance throughout the product lifecycle: pre-launch activities, onboarding, marketing launch plans, strategic/tactical launch plan execution, and followed by ongoing continuing education programs. The successful candidate will contribute in-depth sales & training expertise, work closely with internal stakeholders up to senior levels and external partners (including creative agencies), with the capacity to develop a budget/resourcing plan to support the needs of the business. This position offers an extraordinary opportunity for individuals interested in building a US company with immediate opportunities in breast cancer and other oncology indications with high unmet needs, while working with a cross-functional team rich in exceptional talent.

This position will be responsible for the clinical operational strategy and overall delivery of clinical trial(s). This position will be responsible for clinical operations planning, oversight and execution of the most complex global studies within one or more clinical development programs. As a clinical operations expert this role includes three primary accountabilities.  First, development and coordination of operational approaches and delivery.  Second, cross-functional team leadership for critical global studies.  And third, oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to timelines, budget and quality plans. 

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.  

Reporting to the Vice President, External Manufacturing, develop and Implement the lifecycle of contract manufacturing strategy for commercial or clinical products at one or more monoclonal antibody third party manufacturing organizations (CMO).  Activities include CMO selection, process technology transfer, CMO management, and routine cGMP manufacturing monitoring and management.  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 across the whole global supply chain. Build and Manage team of Persons in Plant to cover global supply chain.