Senior Manager, MS&T
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 providing technical leadership to drive tech transfer and process validation initiatives for AlloVir’s clinical and commercial cell therapy manufacturing processes. This individual will engage both internal and external partners to ensure robust, scalable and efficient manufacturing processes into clinical or commercial manufacturing facilities. He/she will provide the technical expertise in leading CDMOs to establish GMP processes, driving process improvements and quality investigations. This position requires an experienced individual with a core competency in upstream GMP processes and passion to apply technical and management skills to drive complex cell therapy manufacturing process and deliver transformative medicine to patients.
Responsibilities:
- Lead technology transfer activities ensuring effective information flow, issue resolution, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.
- Identify and implement operational improvements and novel technological approaches to improve yield and key quality attributes.
- Provide technical leadership in quality investigation to address deviation and implement change controls.
- Lead process validation and continued process verification and associated documentation.
- Author, review and approve technical documentation including protocols and reports related to engineering run, GMP run and PPQ runs.
- Collaborate with external partners to ensure success of tech transfer and process validation.
- Participate in cross functional program teams as the MS&T representative, and influence cross-functional partners to support MS&T objectives.
- Manage 1-2 junior engineer or contractor.
Qualifications:
- Degree in Chemical Engineering, Bioengineering, Biology or related field, and appropriate years of experience: MS and 6+ years of work experience, BS and 8+ years of work experience
- Technical expertise in cell culture, biopharmaceutical process development and/or manufacturing for biologics, cell and/or gene therapy processes.
- Experience in tech transfer, process characterization, process validation is highly desirable.
- Demonstrated trouble shooting and problem-solving skills.
- Ability to work both independently and as part of a team.
- Experience with closed system processing methods for cell therapies, blood and cell processing technologies, and cell characterization methods is highly desired.
- Strong written and verbal communication skills are required
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.