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US-CA-Berkeley

The Director, Global Supply Chain will be responsible for the strategy, development, implementation and direction of the global end-to-end supply chain for Agenus Inc commercial and clinical products. This individual will work closely with senior leadership to enhance materials management, contract manufacturing, procurement, supply chain and logistics capabilities as the company executes clinical trials, secures commercial product approvals, grows the product pipeline and expands the business nationally and globally.

 

Job ID
2017-1336
US-MA-Lexington

The Validation Engineer is responsible for working closely with functional areas to develop, execute and summarize validation documentation for GMP equipment, systems, processes, and facilities.  The candidate who fills this role is responsbile for all new and existing equipment, systems, processes, and facilities at the Lexington location.

Job ID
2017-1333
US-MA-Lexington

 

The Senior CMC Manager is experienced in the use of project management tools/software and principles who can independently manage program activities for two or more CMC teams ensuring that the Cancer Vaccine program/s stay on schedule and within the expected budget to achieve the program's goals and milestones. The Senior CMC Manager drives the team in the development and successful execution of product development activities through the drug development process and is aligned with management's and Health Authorities' expectations. The Senior CMC Manager must be experienced in product development programs in a matrix-oriented team environment to successful milestone completion. He/she must be able to anticipate obstacles or risks to the plans and to develop mitigation strategies. The Senior CMC Manager is responsible for clearly identifying and reporting up when programs or projects timelines and deliverables are at risk.

This is an excellent opportunity for exceptional highly motivated, inquisitive, and innovative individuals with the desire to be an integral member of a collaborative multidisciplinary team in an entrepreneurial environment and who seek to gain experience in the fast-paced and intellectually challenging environment of a growing company.

 

 

Job ID
2017-1331
US-CA-Berkeley

Overview:

Manage all Facility and monitor EHS operations at the Agenus West site (~25,130 sf). Actively ensure Company compliance with all Federal, State and local permits, licenses, and safety regulations. Reduce business risk through proactive condition based and PM programs, support and foster a working environment that matches Company philosophy. Manage internal services and vendors to agreed service level agreements. Drive maintenance functions as needed through a combination of direct reports, contractors, and or temporary staff.

Manage internal engineering / Facilities Operations and projects, deliver solutions to support business needs. Provide oversight to the Facilities, EH&S and laboratory support teams. Drive and support the integration of corporate Facilities and EH&S policies and procedures.

Job ID
2017-1329
US-MA-Lexington

The Agenus Immuno-modulatory Drug Discovery group (Lexington, MA) is seeking a highly talented and motivated research associate to contribute to the team's efforts of characterizing immunotherapeutic drug candidates aiming to advance research stage programs into early clinical development.

The successful candidate will have primary responsibilities for the design, execution, and analysis of immunology-based assays, including functional assays based on flow cytometry and microscopy using primary immune cell cultures. He/she will provide clear and concise data summaries for technical reports, laboratory protocols, and presentations. The position offers the successful candidate exciting opportunities to develop skills and gain expertise in immuno-oncology as part of an innovative and collaborative team committed to discover, develop, and deliver novel medicines for the treatment of cancer.

Job ID
2017-1325
US-MA-Lexington

We are seeking a highly motivated Research Associate / Senior Research Associate to join the Immunomodulatory Drug Discovery group at Agenus. In this position, the selected candidate will work as part of an integrated research team to advance research stage programs into early clinical development. The candidate will also contribute towards the discovery of novel antibody-based therapies in the field of cancer immunotherapy.

Job ID
2017-1324
US-CA-Berkeley

The Director will joint motivated and newly formed Regulatory Science & Pharmaco-vigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.

 

The RSP aims to maximize opportunities for product approval, its safe use and further development by:

 

  • Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
  • Delivering regulatory milestones and timely registration throughout the product lifecycle
  • Ensuring patient safety by early identification of safety signals, building robust PhV systems and preparing for post-marketing commitments
  • Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration

 

The director regulatory strategy CMC is responsible for overseeing the development and implementation of global regulatory CMC strategies for product development and commercialization. He/she will provide regulatory CMC leadership across projects, teams and committees and will provide strategic and operational leadership for regulatory CMC activities including submission applications and health authority interactions.

 

The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.

Job ID
2017-1321
US-MA-Lexington

 

This is an outstanding opportunity for an experienced regulatory professional in drug development and regulatory strategy in the biotech arena to join motivated and newly formed Regulatory Science & Pharmacovigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.

 

The RSP aims to maximize opportunities for product approval, its safe use and further development by:

 

  • Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
  • Delivering regulatory milestones and timely registration throughout the product lifecycle
  • Ensuring patient safety by early identification of safety signals, building robust PhV systems and preparing for post-marketing commitments
  • Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration

 

The Company is seeking an experienced regulatory leader with over 13 years of experience in the international pharmaceutical industry or consultancy and at least 10 years in global regulatory strategy with proven track record of business impact. Management experience of cross-functional team over 5 years is a prerequisite. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and defending the regulatory position with global health authorities.

 

The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.

Job ID
2017-1320
US-MA-Lexington

Agenus is seeking a highly motivated and qualified Research Associate to join the research biochemistry group to support discovery and development of novel therapeutics for Immuno-Oncology. The successful candidate will possess a strong foundation in protein chemistry and experience with standard protein analytical methods. The candidate will be a member of a highly collaborative research environment within Agenus and is expected to design, plan, and execute experiments independently and as part of multidisciplinary team of researchers. Agenus is committed to developing the employee skills and capabilities necessary for future success.

Job ID
2017-1319
US-MA-Lexington

This is an outstanding opportunity for an experienced regulatory professional in drug development and regulatory strategy in the biotech arena to join motivated and newly formed Regulatory Science & Pharmacovigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.

 

The RSP aims to maximize opportunities for product approval, its safe use and further development by:

 

  • Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
  • Delivering regulatory milestones and timely registration throughout the product lifecycle
  • Ensuring patient safety by early identification of safety signals, building robust PhV systems and preparing for post-marketing commitments
  • Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration

 

The Company is seeking an experienced regulatory leader with over 13 years of experience in the international pharmaceutical industry or consultancy and at least 10 years in global regulatory strategy with proven track record of business impact. Management experience of cross-functional team over 5 years is a prerequisite. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and defending the regulatory position with global health authorities.

 

The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.

 

 

Qualifications

 

The successful candidate should possess the following qualifications, experience and attributes…

 

  • University qualification in a relevant life science discipline; preferably with a higher academic qualification (PhD, PharmD)
  • Substantial experience gained in regulatory affairs and strategy 13+ years, via roles in the pharma/biotech industry, consultancy or regulatory health agencies
  • At least 10 years in regulatory development strategies, managing complex projects and FDA, EMA and other major agency consultations
  • Track record of regulatory approvals in oncology is a must, including hands-on experience across all phases of development and post-marketing
  • In-depth understanding of the current European and US regulations and the wider regulatory environment and trends – and their implications for the global drug development process
  • Knowledge of ICH, FDA and EMA guidelines and awareness of evolving regulatory environment
  • Established network and credibility with key customers including health authorities and industry

 

Core Competencies

 

  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Ability to influence and lead cross-functional team toward successful negotiation with agency
  • Ability to influence and interact effectively with internal and external customers
  • Ability to work effectively across functions in drug development and commercial organizations
  • Team player with good interpersonal skills
  • Strong oral and written communication skills
  • Good presentation, organization and planning skills
  • Able to undertake significant travel (approx. 30% a year)
  • Fluency in English, written and spoken - knowledge of other languages valuable

 

Job ID
2017-1317
US-MA-Lexington
  • As part of a team, this person will be supporting in vivo studies and analyzing samples obtained from these studies.
  • Responsible for conducting and managing in vivo studies to determine the efficacy of both small molecule and biotherapeutic approaches.
  • The evaluation and development of new technologies, biomarkers and in vivo models are key components of this position.
  • Any background and knowledge in immunology is a plus for this position.
  • Plan and conduct of experiments in vivo studies in support of Inflammation & Immunology therapeutic portfolio
  • Formulation of compounds and administration of drugs and experimental compounds by various routes
  • Collection of blood and various tissues
  • Ability to learn and conduct other animal-related techniques
  • Ex vivo analysis of animal samples
  • Maintain well-organized records and documentation
  • Data entry and analysis
Job ID
2017-1312
US-CA-Berkeley

Combine your experience and innovative, entrepreneurial spirit by joining our growing team in Berkley, CA. Agenus Bio is pleased to offer the opportunity to make a difference in patients’ lives and join an organization in the delivering innovative curative treatments for cancer. As an essential member of the HR team, you will help build a Human Resource function for our Berkley, CA site. Initially, a big part of your day to day will be working with managers to source and attract exceptional Talent, onboard new hires as well as to act in a consultant capacity, helping your leaders manage change and implement organizational development solutions, programs and policies. Over time, the HR Business Partner will be exposed to areas in talent development, work force planning, succession planning, labor and employee relations, training, and performance management.

 

 

Job ID
2017-1311
US-MA-Lexington

Agenus is seeking a highly motivated individual with cell based analytical bioassay experience to work on innovative Cell Therapies for cancer treatment. This Senior Scientist position reports to the VP of Precision Medicine and Manufacturing.

 

The successful applicant will have primary responsibilities for the design, conduct and oversight of new potency assays for Agenus’ cell therapy products.

The person will also responsible for the development of assays to explore the optimal subset of cells to be used in clinic and compare these with innate adaptive immune cells.

 

 

Job ID
2017-1310
US-MA-Lexington

Support data management activities for all the assigned Agenus' clinical studies

Job ID
2017-1309
US-MA-Lexington

Hierarchal Position

  • the Associate Director of Clinical Operations will report directly to the Executive Director of Global Clinical Operations and is tasked with the following overarching responsibilities:

In collaboration with other Research and Development departments and applicable Business Unit partners,

  • Responsible for the clinical strategic and operational oversight, management, and delivery of one or more clinical development programs in support of Agenus’s development strategy.
  • Authors, provides input, and/or oversees program and/or study level documents.
  • Manages all internal and external team activities including allocated CROs and third-party vendors.
  • Manages financial aspects of assigned clinical program(s) or study(ies).
  • Responsible for strategic initiatives for process and business improvements within Clinical Operations
Job ID
2017-1307
US-MA-Lexington

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.

Job ID
2017-1305
US-MA-Lexington

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.

Job ID
2017-1303
US-MA-Lexington

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.

Job ID
2017-1302
US-MA-Lexington

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.

 

Job ID
2017-1301
US-MA-Lexington

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.

Job ID
2017-1298