Senior CMC Project Manager
About AlloVir
AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.
We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.
Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.
Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.
At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.
The Role:
This position is responsible for planning and driving execution of CMC projects of all clinical phases, including process, operational, material, compliance improvements, analytical development, technology transfer, comparability, and regulatory filing support within internal and external matrix organizations. This individual will partner with Manufacturing, Technical Services, Quality, Supply Chain, and other key internal and external stakeholders to ensure successful project execution on budget and on time through application of expertise in projects management tools and processes. This position requires an individual capable of organizing a complex network of interrelated deliverables and working cross functionally inside and outside the business to deliver transformative cell therapies to patients.
Responsibilities:
- Planning, execution, and Implementation of cross-functional programs and projects
- Apply project management expertise and best practices in the planning, initiation, execution, and tracking of project activities.
- Institute comprehensive work breakdown structures for all team deliverables and manage through risks/issues/decisions through completion.
- Identify resource and schedule constraints, key risks, and issues to be resolved and proactively drive the development of contingency and/or risk mitigation plans,
- Ensure exceptional reporting and communication including escalation of risks and issues and coordination of decision making. Develop and implement formal communication protocols and tools including dashboards, management reports, monthly/quarterly updates, and any other product specific information as needed.
- Continuously drive improvements and ensuring effectiveness of Program Management processes and tools
- Lead/participate in the development, implementation, and sustainability of standardized approaches to program/project management with respect to schedule milestones, resources, and costs.
Qualifications:
- Bachelor's degree and 8-10 years of related biopharmaceutical work experience or Master’s degree and 6-8 years of work experience. Minimum of 2 years of project/program management experience
- Minimum of 3 years leading CMC program / project teams in fast paced environments.
- Proficiency in any PPM (program portfolio management) software tools such as MS Office, CA Clarity, HP PPM, Oracle
- Preferred experience in cell and gene therapy and/or strong knowledge of GMP manufacturing, quality and/or regulatory processes and challenges
- Excellent communication and negotiation, strong presentation, problem solving, and facilitation skills
- Demonstrated ability to manage cross-functional teams and inspire collaboration across the business.
- Exceptional organizational and time management skills; ability to multi-task in fast paced environments.
Why join AlloVir?
AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.
We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.
As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.
Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.
AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.