Click column header to sort
-
The Manager, Deviation and CAPA ensures the deviation process meets Industry and Immunomedics expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained. Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. Performs CAPA effectiveness checks as required. Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. Initiates Escalation activities as required. Participate in escalation meetings as required. Performs trending analysis of deviations, CAPAs, OOS as required. Supports APQR program with regards to providing analysis for deviations and CAPAs. Supports the preparation and presentation of trend reports for Quality Management Reviews. Implements and ensures adherence of appropriate regulations and Immunomedics quality standards.
-
Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP)
-
Responsible for the operation of mammalian cell culture production processes in compliance with cGMP regulations.
-
Immunomedics is seeking a highly motivated GxP LMS Training Specialist who is interested in joining our fast-paced, dynamic environment. The successful candidate will serve as the subject matter expert of the Learning Management System (ComplianceWire).
The GxP LMS Training Specialist is responsible for supporting the implementation and execution of corporate quality training programs related to key training initiatives, applicable regulatory requirements, and is responsible for the continuous improvement of the LMS for the organization. The GxP LMS Training Specialist will partner across functions to ensure that Training and Continuous Education programs are properly maintained, implemented and communicated across sites.
-
The Process Engineer, Single Use Technology will be the technical resource for the Immunomedics Single Use program, providing engineering expertise to equipment and process assessment and optimization, technical document authoring, continuous improvement, equipment and process quality system ownership, and on-the-floor mentorship for all large-scale processing as it pertains to single use technology.
-
The Associate Director, MSAT will be the technical and leadership resource for the MSAT department, purposed to provide engineering and scientific expertise to tech transfer, process scale-up, equipment and process optimization, technical document authoring, continuous improvement, equipment and process quality system ownership, and on-the-floor mentorship for all large-scale processing.
-
Supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external process and systems supporting Immunomedics clinical trials. Provides GCP compliance support to Clinical development and operations, including GCP QMS (quality manual, SOPs, WPs, etc.) development/maintenance. Actively contributes to the risk-based GCP audit program, including CAPA, GCP 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, PV, medical affairs.
-
Responsible for providing on-the-floor direction to the technicians responsible for providing support to Upstream and Downstream manufacturing areas. Plan and prioritize the parts washer and autoclave schedules to ensure manufacturing requirements are met. Review autoclave and washer forms and run records at completion. Routine review of on-the-floor sanitization log books throughout the manufacturing areas. Manage 3rd party sanitization to ensure proper room cleaning is performed for the following day startup activities.
-
Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP)
-
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.
-
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.
-
This position 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.
-
The Quality Control Senior Analyst performs product release and stability testing using gel based and capillary electrophoresis methods, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.
-
The Quality Control Supervisor is responsible for cGMP QC release and stability testing of biopharmaceutical drug products, drug substances and process intermediates using chemical analysis, and radiolabeling of materials. Authors and reviews protocols and executes testing to support analytical chemical method validation and technical transfer of methods. Participates on cross-functional project teams as a subject matter expert. Develops and trains staff.
-
The Microbiologist II 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 Senior Clinical Digital Manager – primarily supports Clinical Operations & Clinical Data Sciences (CO&CDS). Position is responsible for data foundation activities such as: data linkages and visualization of the Immunomedics (IMMU) clinical data; building a secure formatted data repository and utilizing other digital tools in the operational delivery of clinical study trials. The candidate is expected to have broad business systems knowledge and experience in supporting clinical EDC, clinical data sciences planning, oversight and execution of complex global studies across multiple-phases of clinical trials (I – III). As a Subject Matter Expert (SME) for Clinical Digital Solutions, this role includes three primary accountabilities. First, supporting innovation and continuous improvement of digital solutions across the organization by creating awareness of the usage of digital systems in clinical processes. Second, leveraging clinical digital solutions to achieve higher efficiencies and standards that improve cross-functional team collaboration and coordination of operational approaches for delivering studies. And third, provide oversight or management of interactions with CROs and other digital systems vendors to ensure studies are conducted on time, of good quality and within budget. Works collaboratively with Clinical Digital Solutions and with IT in support of clinical and related enterprise digital solutions.
-
The Senior Microbiologist will be responsible for performing environmental monitoring, microbiological testing of pharmaceutical grade water, in-process materials, test methods verifications/validations and development and equipment evaluation and qualification in compliance with cGMP guidelines and SOPs.
-
This is a technical role with high leadership requirement position that will be responsible for initial set-up of the “Study Set-up Unit” of the Clinical Data Management Department for Data Management Operations, including establishing the infrastructure and programming environment, as well as DM related metrics.
This role will require Subject Matter Expertise in the area of “Study Set-up Unit” for Clinical Data Management, and frequent interactions with Senior Leadership and Key Stakeholders, including but not limited to Statistical programming, Statistician, IT, Medical, clinical Operations and the Data Management Leadership Team.
The goal assigned to the individual in this role will be to design, build, and implement the eco-system of the SSU to enable study to be initiated, conducted and closed out.
-
Provides executive secretarial and administrative support to the CTO, Senior VP of Manufacturing, Engineering and Production Support and the VP of Supply Chain Manufacturing.
-
The Principal Biostatistician works directly with the medical project team to provide input into and insure the appropriateness of the statistical analysis methods described in the clinical study protocol. S/he develops statistical analysis plans consistent with the clinical trial primary safety and efficacy end points. The Biostatistician reports to the Director of Biostatistics.