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Responsible for maintaining site instrument calibration program and supporting process equipment and utility systems for the Immunomedics manufacturing site. Operates within cGMP and regulatory compliance, ensuring systems are calibrated and operational within site and regulatory requirements. Capable of developing and enforcing procedures, documenting work as/when performed through site CCMS and maintaining a clean/organized workplace supporting site compliance and quality standards.
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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, Microbiology oversees the Microbiology department to ensure compliance with SOPs, cGMP, USP, and EU regulations by all personnel. Assists with the development and implementation of policy and directs and administers day-to-day Microbiology activities, such as sampling, training, and testing. Trending of environmental sampling and implementing corrective and preventative plans of action for any out of trend occurrences. The QC Microbiology Manager provides leadership and manages performance of staff and provides support for the site microbial control policies and procedures during interactions with the Health Authorities.
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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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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.
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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 Quality leadership and oversight during manufacturing of in-process, upstream and downstream, and batch release 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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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.
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Responsible for providing logistical support to one or more study teams through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
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This position requires a sound working knowledge of clinical data management processes and database systems within a multi-disciplinary team environment.
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Senior Manager/Associate Director CMO provides oversight of the CMO manufacturing site(s). Provides project management and operational support for commercial and clinical manufacturing operations for the manufacture of small molecule used in the Supply of Antibody Drug Conjugates at Contract Manufacturing Organizations (CMOs). As of a colleague of a remote external team, the selected candidate acts as primary contact for assigned manufacturer(s) and assists in maintaining excellent supplier relationships and timely production schedules.
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Reporting to the Vice President, Global Head of Safety and Pharmacovigilance, with the Senior Medical Director, the Medical Director will be responsible for the oversight of medical safety functions for Immunomedics’ products, both those in clinical development and marketed products. The 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, with the Senior Medical Director, will lead cross-functional Safety Management 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.
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Provides overall guidance to the statistical programming function in support of clinical trial data analysis, clinical study reports, publications, interim analysis, ad hoc analysis and submissions and is accountable for the statistical programming infrastructure. Develop resourcing and budgetary plans to meet the demands of the statistical programming function and ensure process improvement by review of existing processes or developing new processes. Interacts with other functional heads within the clinical development organization to ensure the application of standards across different projects to increase the efficiency and utilization of resources and ensure strong collaboration between Statistical Programming function and other functions. Manage and mentor Statistical Programming staff and provide guidance to programming strategies across multiple studies/ programs. Ensures the implementation of best industry practices to ensure quality of reporting and meeting regulatory requirements. Manages all programming activities related to regulatory submissions.
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Reporting to the Vice President, Global Head of Safety and Pharmacovigilance, the Senior Medical Director will be responsible for the oversight of all 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 will lead cross-functional Safety Management 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 the 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.
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Associate Director, CMC Regulatory Affairs will translate regulatory requirements working effectively with the respective process and manufacturing teams to collaborate, implement and interact meaningfully into workable strategies and plans for various stages of drug development of drug substance and drug product. This individual supports CMC regulatory filings for the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs.
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The candidate for this role is an experienced leader capable of working independently while taking responsibility for the clinical operational strategy and overall delivery of clinical trial(s) delivery. The Clinical Operations - Director of Clinical Programs is 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.