Click column header to sort
-
We currently seek motivated professionals who share our passion for science and our dedication to improving the lives of cancer patients. The Executive Director, Trade and GPO is a key leadership position within the Immunomedics commercial team.
The Executive Director will develop and implement Immunomedics go to market strategy for trade distribution. The individual will play a key role in the execution of the order to cash process with the selected 3PL and will develop the specialty distribution network. This individual will develop strategic account plans and orchestrate effective coordination, collaboration and communication among the cross-functional matrix to execute the plans and ensure objectives and performance targets are achieved. The Executive Director, Trade and GPO will report to the Vice President, Sales and Marketing
-
The Process Engineer 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 Director, Protein Purification will report to the VP of Process Sciences, and will lead the development of robust, cost-effective, and well-characterized 2nd generation processes for purification of monoclonal antibodies and cell culture derived recombinant proteins for commercial and pipeline drug development. The ideal candidate should be in expert in protein biochemistry and bioprocess techniques as it relates to protein purification process development.
-
Immunomedics is seeking a Manager of Validation to provide experienced, technical, and scientific leadership for process validation, equipment qualification, cleaning validation, technology transfer and process improvements at its Morris Plain site and at CMOs for monoclonal antibodies, fusion proteins, and antibody/protein biopolymer drug conjugates. Successful execution of this role requires a strong scientific and engineering approach, established expertise in upstream and/or downstream process development for therapeutic proteins, process characterization, process validation, and technology transfer experience. The ideal candidate has a track record of establishing mutual respect, trust, and close collaborations with internal and external organizations, and the ability to interact effectively at all levels. This position will report to the Director, Validations.
-
The Associate Director (AD), Clinical Operations is responsible for the strategic planning, oversight and execution of Ph1/II/III studies across indications or programs. The AD of Clinical Operations will have program oversight responsibilities while also managing a study or studies. Responsibilities include, but are not limited to, establishing program study timelines and budgets, overseeing the day-to-day operations of clinical trials from study design through close-out, ensuring studies are conducted in accordance with appropriate regulatory requirements and within established timelines and budget, leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The AD of Clinical Operations is also responsible for leading or contributing to company process improvement initiatives.
-
Provide Quality assistance and oversight during manufacturing of in-process upstream and downstream, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Note: Temporary Assignment with Potential to become Permanent
-
Responsible for all Quality Assurance related aspects of material handling, storage, shipping and control, and all associated documentation. This position may also be cross-trained on Product Disposition and Regulated Document/Training functions.
-
Provide Quality assistance and oversight during QC processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of all cGMP documentation and source data complies with all applicable cGMP regulations, Good Documentation Practices and Data Integrity Guidelines.
-
Quality Audit Services establishes the programs and tools for conducting audits to company requirements and standards as well as official regulations including U.S. Title 21 Code of Federal Regulations Parts 210, 211, 600 series, 803, 806, 820 among others not detailed here for GMP, GCP, GLP (i.e, GxP) compliance. The auditing services cover internal operations and external contract GxP manufacturing and laboratory service providers, audits related to bioresearch monitoring activities, and audits of suppliers of those commodities deemed critical to manufacturing operations. The department head establishes the Approved Supplier List in accordance with the approved Supplier Qualification Program, and is responsible to actively manage the qualification/disqualification of suppliers on the list.
-
This position is responsible for documenting complaints in the complaint record/files, evaluating complaints, investigating complaint allegations to the established label and labeling to examine for ambiguous statements, and/or gaps in the instructions for use. This role investigates the manufacturing of the product, including review of relevant production and control records, and compiles the investigation report for the complaint file.
The primary group that performs complaint intake is a contracted call center, thus complaint intake is expected to be a very minor job duty. Even so, in an ad hoc situation this role performs the complaint intake actions.
This role serves as the business owner of the Corporate Quality Systems-related content contained with the non-conformance module for complaints (Veeva QMS).
-
The Quality Management System Specialist executes daily activities and maintains focuses on the Change Control, CAPA and Risk Management systems.
This position ensures compliance with established and approved quality systems.
-
Creates, reviews, and revises technical documentation of procedures and practices associated with VEEVA.
Ensures appropriate maintenance of technical documents, provides various support, and coordinates activities for the Document Control department.
-
Associate Quality Manager CMO provides oversight for the Quality Assurance for the CMO manufacturing site(s).
This would include Batch manufacturing processes, CMO Quality Systems such as change control process, documentation processes, CAPA, Risk Management and QA Validation oversight.
This position may also be cross trained to cover other QA functions as needed.
-
Ensure satisfactory completion of assigned validation projects encompassing equipment, instruments, cleaning, and process areas for the entire validation lifecycle. Lead the project team to fulfill the validation requirements. Develop and execute SOPs and protocols (IQ/OQ/PQ). Write associated summary reports. Ensure compliance with the Change Control system for validated state.
-
-
The Project Engineer will be responsible for planning and executing various types of projects to support the reliable functioning of the manufacturing operations and the supporting facilities and utilities.
-
Primary role of the QC technician/analyst position is receiving, inspection and sampling of incoming raw materials as assigned by management. In addition, the technician/analyst also supports routine sampling and testing of utility samples and raw materials.
-
The Senior QC analyst is responsible for routine testing of incoming raw materials for release and utility samples testing. The incumbent will be supporting raw materials and adventitious virus safety testing of bioreactor harvests at third party provider. This position also include responsibility of authoring technical reports, specifications for incoming raw materials and evaluation of change notifications, as directed by the group manager
-
The QC Analyst performs routine sampling, testing, and data reporting and performs support activities such as receiving, inspection and sampling of incoming raw materials as assigned by management. The incumbent will also support utility sampling and testing on as needed basis.
-
The Technical Sciences Director, Quality Control will be responsible the stability program for all clinical and commercial biologic Drug Substance and Drug Products across internal and external manufacturing sites. The Director is responsible for the product stability strategy and manages internal logistical and technical operations for QC that includes sample management and the global product reference standards program.