Senior Director, Head of CMC Technical Services
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 leading the CMC Technical Services team inclusive of Manufacturing Sciences and Technology (MST), Process Development (PD), Analytical Development (AD), and Process Data Systems and Analytics for both clinical phase and commercial phase T-cell therapies. The incumbent will partner with key stakeholders across the Science and Technical Operations organizations to define and drive a holistic CMC technical strategy that collects, organizes, and leverages product and process knowledge thru the full manufacturing value stream in alignment with relevant regulatory guidelines and cell therapy industry best practices. Reporting to the Head of Technical Operations, he/she provides the scientific leadership, strategic thinking, and results focus to reliably meet and/or exceed the company’s CMC goals while supporting high levels of quality. This position requires an individual capable of identifying and implementing innovative technical strategies in support of delivering transformative therapies to patients suffering from or at risk of severe and life-threatening viral disease.
Responsibilities:
- Provide technical leadership to process engineers, scientists, and associates including overseeing the design and execution of studies, process/product investigations, data analysis of results, and writing/review of technical reports. Must stay current with relevant technologies and forward thinking to identify new approaches.
- Recruit and develop staff to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognitions practices.
- Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variations. Represent company as an SME during regulatory interactions.
- Provide technical leadership and oversight to the technical transfer of processes to new CMOs including driving facility fit assessments, process gap / risk assessments, and supporting the development of batch records and procedures, management of change controls, and establishing process and equipment training programs.
- Define and drive the full process validation lifecycle from process characterization, to process performance qualification (PPQ), to continued process verification in accordance with cGMP and ICH guidelines and industry best practices.
- Establish a robust product comparability approach inclusive of both routine and characterization analytical testing to enable late stage and commercial phase process improvements. Present and defend approach to regulatory agencies.
- Establish department, and individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department.
- Develop and manage department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments.
- Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.
Qualifications:
- Bachelor's degree and Master’s degree in Life Sciences or Engineering and 12+ years of relevant work experience. PhD preferred.
- Minimum of 7 years leading development / technology teams in fast paced environments.
- Expertise in cell culture-based development and manufacturing. Preferred experience in cell and/or gene therapy products and processes.
- Exceptional ability to compile, analyze, and interpret quantitative data and facts; strong troubleshooting and problem-solving skills and the ability to drive timely fact based decisions.
- Excellent written and oral communication skills both internal and external.
- Ability to gown and navigate cGMP manufacturing areas.
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.