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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.
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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.
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Associate Director of Quality Systems provides oversight to Quality Systems such as change control process, document control / management, Risk Management and, Computer System Validation (CSV), and general QA Validation oversight. Quality System group will also manage Quality System updates and provide day to day management to these Quality Systems. QA System group will provide trending for Quality Systems. This position may also be cross trained to cover other QA functions as needed.
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The GMP Training Manager is responsible for ensuring that the training and qualifications systems are in place to assure that personnel are trained, qualified and competent to perform their assigned job functions in accordance with regulatory requirements and IMMU Policies and Procedures.
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Manage GMP Training Program, company-wide, and assure that company-wide GMP training is performed in compliance with Current Good Manufacturing Practices, company policies and procedures.
Oversee Administration of the ComplianceWire Learning Management System (LMS) including workflows for user access/ security roles, assignments/ curriculums / user groups, SOP revisions, data entry/ organization, custom fields
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Sr.Director of CQA provides Strategic vision and oversight for the Clinical Quality Assurance System including Clinical Standards development and maintenance, Clinical Audit Program, Good Clinical Practice Training and Clinical Inspection Readiness Program. The incumbent will oversee internal quality systems and processes within Clinical and R&D functions to ensure compliance with applicable regulations and requirements; in collaboration with Line Functions or other business process owners, ensure that applicable clinical development, research related processes and quality standards are designed and implemented in line with health authority requirements. Drives the implementation of robust GxP (GCP, CSPV, PV) Quality Management System and Processes for all regulated areas where clinical trial activities are allocated and or executed. Facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives within the organization. Ability to share/ implement vision and strategy within the responsible line functions as well as globally. Directs globally Clinical processes for improving efficiency by optimizing processes necessary for continuous improvement at the regional and global levels. Together with Management teams, plans, supports conduct and reports Clinical Research and Pharmacovigilance quality assessments at regional level and supports GCP/CSPV/PV inspections across the organization and affiliates.
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The Manager, CMO - Quality Assurance is responsible for managing activities within Quality Assurance for all CMO (Contract Manufacturing Operations). This position also contributes to the completion of routine technical tasks and any additional quality task identified.
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Manages the Clinical Quality Assurance System providing oversight to Clinical Standards development and maintenance, Clinical Audit Program, Good Clinical Practice Training and Clinical Inspection Readiness Program. The CQA group will also manage Quality System updates and provide day to day compliance assistance to Clinical Study Teams.
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Executive Director, External Manufacturing Quality will provide oversight to External CMO Quality, Material Supplier and Service functions impacting product quality. As part of this role, ED, External Mfg Quality will develop and maintain metrics to monitor CMO and supplier’s performance to IMMU quality and service standards. In addition, the ED, External Mfg Quality will support the development and implementation of processes to adequately manage the supply and service base to deliver expected quality, service and cost performance. The incumbent will develop and manage CMO / Supplier governance process, provide oversight to Quality agreements, and, where appropriate, 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.
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Responsible for Quality oversight for the warehouse and raw material release. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations in the warehouse. Assure that raw material released complies with all applicable regulations and guidelines.
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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.
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The QC Manager, Contract QC provides oversight of the contract testing site(s). Provides project management and technical/operational support for commercial and clinical release, stability and characterization testing of Drug Product, Bulk Drug Substance and Antibody supporting manufacture of Antibody Drug Conjugates at Contract Testing Organizations (CTOs). The selected candidate acts as primary contact for assigned testing laboratories and assists in maintaining excellent supplier relationships and timely delivery of results to support batch release and creation of technical reports.
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This is a hands-on role acting as a site subject matter expert on characterization and management of reference standards. Through coordination of in-house and contract laboratories, the QC Scientist – Reference Standards coordinates the sourcing, manufacture, testing and release of product reference standards for antibody drug conjugate products and product intermediates, provides technical input and manages the supply of product reference standards, ensuring continuity of supply across a global network of in-house and contract GMP testing laboratories. Responsibilities include development of testing protocols, review of batch records, release of test results and control of inventory.
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Responsible for downstream manufacturing (purification) in compliance with cGMPs and SOPs and supervises a team of Manufacturing Specialists.
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Responsible for downstream manufacturing (purification) in compliance with cGMPs and SOPs and manages a team within the Manufacturing department.
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Provide daily Documentation support to laboratory and operation by:
- Maintenance of Standard Operating Procedures,
- Support printing control forms, issuance of controlled logbook,
- Storage and archival of control documents and maintenance of Documentation Control Rooms
- Maintenance of Veeva Documentation system,
- Issuance of batch record, control number and part number
- Provide support during regulatory inspection
- Process Document change controls and Document change orders
- Provide cross training to team members
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Provides overall guidance to all clinical trials data collection, analysis and reporting within the organization, overseeing the Biostatistics, Data Management and Statistical Programming functions. Participates in portfolio and protocol development meetings to provide input into the development strategies and ensure that the necessary resources and processes are in place to achieve the goals of these strategies. Develops resourcing and budgetary plans to meet the demands of clinical trials within their functional areas. Ensure compliance of all data processing activities with federal regulations and industry guidelines. Advocates data quality and builds processes to insure data quality in all Clinical Data Sciences deliverables. Works collaboratively with peers and ensures collaboration within the Clinical Data Sciences organization, encourages team work and compliance with corporate policies and guidelines.
Drive cross-functional team execution and perform as a subject matter expert, based on demonstrated clinical data sciences expertise, extensive leadership, and operational experience. Provide operational and strategic leadership within the clinical data sciences organization and be responsible for consistent and successful execution of all aspects of the clinical data sciences function. Serve as a role model for leadership with both internal and external stakeholders.