Scientist / Sr. Research Associate, Analytical Development (Contractor/Consultant)

Job Title: Scientist / Sr. Research Associate, Analytical Development (Contractor/Consultant)

Location: Waltham, MA

Report to: Director, Analytical Development

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.

Purpose & Scope:

Highly motivated and technically proficient individual to join our team and contribute to and advance the development of cell therapy products. This individual will work closely CDMO for analytical tests development with an understanding of Quality by Design (QbD) using Design of Experiment (DoE) approach and collaborate closely within the team and across functional groups (R&D/QC) to advance AlloVir’s pipeline programs.

Essential Job Responsibilities:

• Works close with CDMOs and CROs to develop and optimize analytical tests required for product development and scale-up.
• Demonstrates solid knowledge of cell biology principles and meticulous technical aptitude for analytical methods.
• Develops strategy and technologies to perform experiments and analytical procedures, applying a variety of scientific principles.
• Evaluates and defines analytical approaches to meet global regulatory guidelines.
• Analyzes data, draws conclusions, writes technical reports and makes suggestions based on results of experiments.
• Coordinates research efforts with CRO and CDMO to make key technical contributions.
• Drives the design and analysis of analytical tests, including identifying and applying innovative techniques and methodologies.
• Provides design and analysis support for deviation investigations and evaluation of analytical method development, batch records, and SOPs.

Qualifications:

Required:

• BS with 4+, MS with 2+ or PhD with 0-3 years of relevant industry experience.
• Ability to work independently as well as part of a team
• Self-reliant, self-motivated, detail-oriented, highly organized
• Willingness and ability to learn new skills
• Four or more years’ experience with aseptic tissue culture technique
• Working knowledge of molecular and cell biology analytical methods, such as flow cytometry, ELISA, coculture, and PCR based assays
• Excellent communication skills
• Ability to plan experiments, analyze data provided by CDMO, and write concise reports

Preferred:

• Prior industry experience, preferably CMC
• Experience with cell therapy
• Experience working under GLP/GMP
• Knowledge of automated methods for cell analysis
• Experience with assay qualification/validation for cell therapy products
• Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance

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.