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.  

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.

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.

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.

The QC 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

Responsible for leading upstream process development, including generation and cloning of production cell lines and cell banks and development of scalable fed-batch bioreactor processes for all commercial and clinical products under cGLP and cGMP guidelines.

Primary function in the Upstream Process group of Process and Manufacturing Sciences to apply molecular biology techniques in the design and generation of new vectors and cell lines. Participate in core upstream process development activities including small-scale mammalian cell culture and bioreactors. Interface with analytical team to develop molecular-biology-based analytical methods for characterization of clinical, commercial and new products.

Responsible for development of liquid and freeze-dried formulations of all commercial and clinical products.

Manage the lifecycle of contract manufacturing activities for commercial or clinical products at one or more Drug linker 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 updates and reports to Executive and Senior management, participate and co-ordinate JSC and business review meetings

This position will help manage the overall accounting and processes related to inventory and cost of sales in a manufacturing environment. This person will support the creation, implementation, and management of the Company’s inventory and cost accounting processes, policies, and documentation as it transitions to commercialization. This person will assist in the implementation and maintenance of a new ERP system. As the process owner and subject matter expert, working in partnership with supply chain, manufacturing, quality and manufacturing support, this person will ensure the ERP implementation is completed timely and accurately. The scope of the implementation will include Bill of Material, Routings and Recipes. Upon commercialization, this position will be responsible for managing the accounting for inventory, cost of sales, supply chain processes, ensuring compliance with GAAP, SOX, and SEC requirements. This position includes inventory documentation, accounting and analyses, inventory cost validation, P&L analysis and reporting, and forecasting. This person will work closely with our supply chain, commercial operations team, 3rd party logistics provider, and will interact directly with our external auditors.

The Associate Director is responsible for the vendor oversight for Safety and Pharmacovigilance operations to ensure compliance with global regulatory requirements, and to support proactive safety surveillance and benefit risk assessments, and risk management, for both development and future marketed products. This includes safety systems support (e.g. global safety database), safety data collection and processing, aggregate analyses and reporting, partnering with the Clinical QA Head on quality management (e.g. standard operating procedures, quality standards, metrics, training, inspection readiness, corrective action plans), maintenance of Reference Safety Information documents, and reporting to health authorities. Management responsibilities include contract personnel and direct reports. This position has a key role in developing and executing innovative, integrated, scalable, and cost-effective solutions, utilizing state-of-the-art technologies and best-in-class processes, aligned with corporate goals.

The Director, External Manufacturing Quality provides oversight to site inspection preparation and to oversee External CMO Quality functions. As part of this role, this position will maintain a compliance scorecard, manage governance process, provide oversight to Quality agreements, and CMO day to day Quality oversight. Supports CMO product release by the QA Operations Group. This position may also be cross trained to cover other QA functions as needed.

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.

Supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight of the quality management system development and maintenance in support of phase I-IV clinical trials. Must be comfortable and thrive in biotech small company, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient to effectively manage multiple projects and responsibilities concurrently.

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.

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

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