The Accounts Payable Supervisor is a hands-on role, responsible for supervising the day-to-day activities of the Accounts Payable department, ensuring proper record keeping, developing best practices and procedures, and ensuring the accurate and timely month-end close of Accounts Payable for both our US and UK offices. The Accounts Payable Supervisor will also work closely with the General Ledger team and report to the Director Finance.
Support CDM activities of all assigned Agenus' clinical studies
Quality Computerized Systems Validation Engineer (CSVE) ensures compliance of systems across the enterprise according to the applicable regulations and the Agenus Quality System, advises on related CSV quality matters, and assists in closing compliance gaps found during audits and inspections.
The position will be responsible for the authoring, executing, reviewing and approval of validation documentation deliverables and work with Quality to approve system release and implementation.
The ideal candidate is a highly organized, detail-oriented and independent self-starter able to manage a wide range of administrative tasks. The candidate must be flexible, able to multi-task efficiently and be committed to helping the organization grow.
Oversees the development, implementation and maintenance of quality assurance systems, lead initiatives in support of the company goals and implement continuous improvements, including all aspects of GMP and (GXP) compliance. Recommends and provides leadership and planning for the implementation of quality assurance (QA) policies and programs. Oversees generation and review of documents used in good manufacturing practices. Also monitors internal audits of Production, Quality Control, Manufacturing and Development areas. Oversees the vendors audits program. Coordinates interdepartmental activities and partners with Associate Directors of Quality at the other site on predefined timelines for alignment of strategic initiatives and prioritization. Reviews and approves reports and other documentation prepared by Development, Production, QA and QC for regulatory submissions and inspections. Assures finished products are dispositioned in accordance to defined regulatory requirements and Agenus procedures and satisfies GXP regulations. May lead investigations, risk assessment discussions, quality system improvement initiatives and resolve potential product quality issues to improve efficiency. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Works with CMO & CRO partners to ensure trouble free pre-approval and regular Regulatory inspections and interactions. Define system to track and manage metrics in support of Site Management Reviews. Lead intersite initiatives supporting quality goals.
The Desktop Support Specialist is primarily responsible for ensuring continuity of IT services for users by providing the technical expertise, assistance and project coordination necessary to deploy, configure and support computer hardware/software products including peripherals, desk/mobile phones and desktop/conference room based audio/video.
The right candidate will be someone who has strong interpersonal skills, along with excellent communication and listening skills. The Desktop Support Specialist must be flexible, well organized and pay close attention to detail.
We are looking for a an experienced IT Manager who can maintain and expand our computer systems. The ideal candidate will be able to manage our computer systems, while looking for ways to grow our IT practice in a cost-effective way to meet future business needs. The IT Manager will be responsible for developing network maintenance and growth plans, creating annual and project budgets, managing the IT staff and keeping the executive team up to date on the latest networking technologies that could help the company to succeed.
We are seeking a highly motivated Research Associate to join a group of researchers evaluating novel targets for therapies in the field of cancer immunotherapy. The successful candidate will have a strong background in immunology, molecular biology and/or oncology research. He/She will work closely with discovery scientists to advance research stage programs into early clinical development, providing both scientific and technical expertise. The successful candidate is expected to have experience in a range of cell biology techniques including: multi-parameter flow cytometry, cell cultures and functional assay development; which is complemented by their experience in general molecular/biochemical methods. He/she is expected to design, plan and execute experiments both independently and as part of multidisciplinary team of researchers. The successful candidate will have the ability to interpret results, troubleshoot technical hurdles and propose solutions to the team. Excellent written and oral communication skills are required for this position.
Senior/Principal Statistical Programmer (depending on experience and background) to support all the asigned Agenus' studies
Statistical programming consultant on assigned Agenus' clinical studies
Lead programmer on all asigned Agenus' studies
Provide daily operational support for all Quality functions including documentation control, issuance and tracking of OOS, Deviation, MRB, EMIs, etc., provide GMP and core competency training, review of quality data (validation, stability, batch analysis, environmental, etc.) and disposition of raw materials, intermediates and final product. Assures that the Equipment Calibration Program and validation complies with the GMPs requirements. Coordinates interdepartmental activities.
The QA Manager, Compliance and Documentation is responsible for providing cGMP compliance and documentation support to the site operations in Lexington, MA. The compliance and documentation team manages and supports to create, review and approve documentation, including standard operating procedures, protocols and reports. This role drives manufacturing compliance to meet various regulatory requirements and quality systems in a GMP environment. The compliance and documentation team will manage deviations, CAPAs and change controls with the support of appropriate personnel. This role also responsible for continual monitoring of quality indicators; trending, tracking and metrics reporting, and escalation, as appropriate.
The Medical Writer will work directly with the Clinical Development and Global Clinical Operations groups on various clinical and regulatory documents ( e.g. study protocols, Drug Safety Update Reports (DSUR), Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This individual will assume lead writing responsibility on up to 6 Clinical studies, in various phases of development, potentially leading to an NDA or BLA, including both regulatory and publication documentation (when applicable)
Agenus (Lexington, MA) is seeking a motivated Research Associate to join the Preclinical Research Group. The selected candidate will work as part of an integrated research team focused on discovering and validating novel T cell-based therapeutics. The candidate is expected to be a member of a highly collaborative research environment within Agenus and with our internal and external partners.
In collaboration with other Research and Development departments and applicable Business Unit partners,
Job Summary: The Vendor Management group sits within the Global Clinical Operations group with the primary responsibility of maximizing the value of the relationships between Agenus and the Strategic CRO and vendor sourcing partners supporting the portfolio (Phase I-IV). The intent is for that value to be translated into improved business terms, increased productivity, reliable quality, strategic innovation, and enhanced working relationships. The Director is expected to collaborate with key internal and external stakeholders, at a departmental and a cross-department with Global Clinical Operations level to ensure Agenus vendors perform to the highest level.
Hierarchal Position the Director of Vendor Management will report directly to the Executive Director of Global Clinical Operations and is tasked with the following overarching responsibilities:
• Partner with Clinical Operations Finance and relevant functions to provide leadership and direction on strategic sourcing and associated operating models.
• Build an understanding of the assigned departmental vendors, their organization and capabilities to anticipate opportunities & risks with those vendors.
• Implement effective governance and assist departments to build strong relationships to maximize performance and value delivered by CROs and other vendors
• Create a culture of joint accountability and enhanced partnering skills within Agenus to ensure CRO / third party vendors’ performance
• Facilitate efficient and collaborative resolution of problems and conflicts with CRO and on behalf of CROs within Global Clinical Operations.
Agenus is expanding a multidisciplinary department with experience in biostatistics, genomics, bioinformatics, biotechnology, next-generation sequencing (NGS), immunology, and molecular biology. We seek a senior bioinformatics scientist to join our team and focus on analysis, visualization and interpretation of high throughput profiling datasets, including NGS and mass spectrometry data.
Agenus (Lexington, MA) is seeking a highly talented, innovative, and motivated scientist to join our Preclinical Research Group. The selected candidate will work as part of an integrated research team focused on discovering and validating novel immunotherapeutics.
The successful candidate is expected to work independently to design, execute, and interpret experiments. These experiments will contribute to the team's effort to create more potent immunotherapies. The candidate is expected to be a visible and vital member of a highly collaborative research environment within Agenus and with our internal and external partners. The candidate will have strong supervisory expertise and contribute to program development and prioritization.
A Senior Manufacturing Associate (MA) will support the clinical development of Mab’s at Agenus West – Process and Manufacturing Sciences Department. Work will focus on the development of large scale production processes under cGMP compliance. Senior MAs will be required to work in both the process development labs and the GMP controlled labs. Work includes a flexible schedule that will allow the senior MA to be “hands on” sampling, trouble shooting, and controlling USP and DSP development/production. This position will actively participate in the technology transfer between Process Development and Manufacturing Sciences.
Conduct external vendor evaluation audits to determine qualifications. Maintain the vendor qualification program, which may include multiple sites. Conducts internal quality audits and risk assessments. Prepares audit plans and understands the specific issues to be evaluated. Executes audits to ensure compliance with recognized standards (i.e., GCP, GLP, GMP), regulatory authorities and in-house and external specifications and standards. Reports discrepancies. Develops formal written reports to communicate audit results to management and regulatory compliance agencies, if applicable, and makes recommendations as appropriate. May facilitate work of external auditors during on-site visits. Individual must have strong working knowledge of cGMPs and applicable regulatory guidance. Must possess excellent written and verbal communication skills and the ability to work independently.