Agenus

Senior CMC Manager

US-MA-Lexington
Job ID
2017-1331
Category
Research

Overview

 

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.

 

 

Responsibilities

Hierarchal Position: This position reports to the Director of CMC with no direct reports

 

  • Strong ability to work with domestic & international multidisciplinary teams
  • Ability challenging team members as appropriate
  • Ability to facilitate alignment across functional areas to achieve goals
  • Ensure sound decision-making principles are applied within the team
  • Ensure that the appropriate PM methods, tools and techniques are utilized correctly to maximize benefits

50% Team Management

  • Manage team to set priorities, agendas, plan activities and facilitate decision making
  • Facilitate timely & productive team discussions.
  • Identify risks and mitigation plans
  • Display ownership of the project's goals and milestones, including ability to independently lead team, priorities and direction and facilitates alignment across functional groups on goal achievement

50% Project Management

  • Establish team goals and objectives with the team and their respective functions. Update progress against agreed-upon, approved milestones.
  • Ensure that project progress and upcoming deliverables are understood by the team and hold team members accountable to their deliverables and timing on schedule.
  • Establish and keep current product strategies, CMC integrated development plan, program schedule(s), and risk management plans.
  • Provide visibility to as necessary when project timing and deliverables are at risk
  • Provide project update and milestone adherence on a monthly basis
  • Provide scenario analysis to support timely decision making to ensure execution per plans
  • Identifies critical issues and discusses with leadership to devise appropriate mitigation plan
  • Ensure effective coordination of activities and/or deliverables across organization
  • Apply all standardized project tools to manage and document team progress as well as to communicate effectively to stakeholders.
  • Coordinate necessary CMC material/information needed for team success.

 

Qualifications

 

Minimum 8 years Project Management experience in a Chemistry, Manufacturing & Control (CMC) environment, with 5-8 years in the biotechnology / pharmaceutical industry experience a must. Bachelor degree in engineering, pharmaceutical sciences or equivalent required. Master degree preferred and/or PMP certification desirable.

 

Agenus is a biopharmaceutical company focused on immunology-based approaches to the discovery and development of novel therapies for cancer and infectious diseases. Agenus has offices and laboratories in Lexington, MA, New York, NY, Berkeley, CA, and Cambridge, UK that collaborate with leading corporate and academic partners around the world.

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