Associate Director or Director, Analytical Science and Technology

Title: Associate Director or Director, Analytical Science and Technology

Location: Waltham, MA

Reports to: 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:

AlloVir is seeking an accomplished analytical leader to provide strategic technical leadership for method lifecycle to support AlloVir’s cell therapy portfolio. In this highly visible role, the individual will: engage both internal and external partners to define analytical requirements; develop and implement analytical lifecycle strategies for development, validation, and transfer initiatives; support regulatory submissions as the analytical subject matter expert; lead the transfer and implementation into QC facilities for clinical and commercial testing. He / She will serve as a key leader in advancing AlloVir’s novel allogeneic viral specific T cell therapeutics and in establishing internal lab capabilities.

This position requires a strategic leader with a fluency in immunology and cellular biology, and a record of prior achievement in the development and validation of analytical methods for large molecule biologics, cell therapy and/or gene therapy programs.

Responsibilities:

• Lead the establishment of the analytical lifecycle management strategy to develop phase appropriate test methods.
• Lead the development, optimization, qualification, and validation of test methods intended for routine and non-routine testing of in-process and drug product release samples. Establish the product characterization, lot release and stability testing panels.
• Lead the establishment of product specifications through application of appropriate statistical tools and scientific rationale.
• Develop analytical comparability strategies through selection of appropriate characterization test methods and justification of comparability criteria.
• Evaluate new assay technologies and innovate novel methodologies to improve existing analytical methods.
• Lead engagement with internal and external analytical partners, including external contract development/testing laboratories.
• Establish assay trending and monitoring program in concert with internal partners.
• Provide oversight of internal and external method development, assay transfer, qualification, and validation projects.
• Participate in cross functional program teams as the analytical representative, and influence cross-functional partners to support PD objectives.
• Support CMC regulatory submissions (IND, BLA, etc.) via authorship, review, approval of relevant CTD sections.
• Identify and implement operational improvements and novel technological approaches to improve yield and key quality attributes.
• Provide laboratory support for manufacturing deviation investigations and evaluation of raw material and consumables changes.
• Author / review / approve technical documents (SOPs, protocols, reports, risk assessments, specifications, etc.).
• Oversee characterization laboratory activities, including method development and routine testing

Qualifications:

• Advanced degree in immunology, cellular biology, biochemistry or related field (PhD preferred) and appropriate years of experience (PhD and 8+ years of work experience; BS and 12+ years of work experience)
• In-depth understanding of immunology and cellular biology with application to development of analytical methods that reflect the drug products mechanism of action (strongly preferred).
• Extensive experience in all phases of the method development lifecycle (development, optimization, qualification, validation, method transfer).
• Demonstrated in-depth knowledge and hands-on experience in the development, optimization and troubleshooting of either bioassays or flow cytometry is required (experience with both is strongly preferred).
• Experience and fluency with the following: flow cytometry / FACS, ELISpot, ELISA, cell culture / cell-based bioassays, microscopy. Prior experience developing potency and/or immunophenotyping test methods for cellular therapies is strong preferred.
• Experience leading the establishment and justification of specifications, including developing specification setting strategy (e.g. batch testing strategy, selection of statistical analysis approaches, etc.)
• Experience in transferring methods to internal and external QC organizations is required.
• Knowledgeable of global regulatory requirements (FDA, EMA, ICH) for bioassay / potency assay’s, analytical method validation, comparability, and drug product stability.
• Fluency in the application of statistical methods and tools for data analysis.
• Demonstrated leadership and critical thinking skills, and ability to motivate and manage team members with direct and indirect reporting status.
• Ability to work independently or as a team member to meet goals and commitments.
• Strong written and verbal communication skills are required. Experience translating complex scientific concepts and data into reports and presentations is 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.

At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of “ImmUnity for all”, we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners.

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.