ABOUT THE POSITION

Aurion Biotech is seeking a highly motivated Senior Scientist, Analytical Development in Cambridge, MA. This position will serve as an integral part of a multidisciplinary team to develop, qualify, and transfer in-process control, characterization, and release assays to support early and late-stage clinical manufacturing and testing of cell therapy products. The individual in this role will work collaboratively with the Research, Process Development, Quality and other groups to make sure assays meet the timeline of characterization and release of cell therapy products.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• A PhD and 3+ years’ experience or an MS degree and 5+ years’ experience in a relevant discipline (immunology, biochemistry, cell biology, biotechnology, or related field) in the pharmaceutical industry and academia, and specifically in gene and cell therapy.
• Experience with cell therapy products is required.
• Demonstrated track record with analytical development supporting early and late-stage development of cell therapies.
• Deep technical understanding of analytical method development for key assays (Flow Cytometry, automated cell counting, dPCR, qPCR, ELISA, cell-based potency) and associated requirements (validation, stability programs, comparability assessments, etc.) across development is required.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• The ability to work in a dynamic, fast-paced, matrix environment, manage priorities and maintain timelines for multiple projects.
• Demonstrated ability to technically trouble shoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate.
• Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required.
• The ability to work both independently and in a matrix team environment is essential.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Knowledge of Manufacturing to develop and innovate next-generation analytical tools for the characterization and
• Familiar with data analytics software such as FlowJo, JMP, and GraphPad Prism

KEY RESPONSIBILITIES

• Conduct various independent laboratory experiments including but not limited to Flow Cytometry, cell counting, dPCR, qPCR, ELISA, cell-based potency assays etc. to satisfy the overall AD objectives.
• Collaborate cross-functionally with other functions including Cell Production, Process Development, Manufacturing, and Quality.
• Author method qualification SOP, method qualification report and test method SOP and other technical documents to support regulatory submissions and other groups.
• Track progress toward project milestones and ensure that deliverables are met.
• Responsible for the development, optimization, qualification, and transfer of GMP-compliant analytical methods and materials that meet US FDA and/or EU regulatory requirements for clinical stage, cell therapy products.
• Train other groups to execute various in-house assays.
• Experience with Quality Control and regulatory requirements for late-stage method development and documentation are highly preferred.
• Other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• A PhD and 3+ years’ experience or an MS degree and 5+ years’ experience in a relevant discipline (immunology, biochemistry, cell biology, biotechnology, or related field) in the pharmaceutical industry and academia, and specifically in gene and cell therapy.
• Experience with cell therapy products is required.
• Demonstrated track record with analytical development supporting early and late-stage development of cell therapies.
• Deep technical understanding of analytical method development for key assays (Flow Cytometry, automated cell counting, dPCR, qPCR, ELISA, cell-based potency) and associated requirements (validation, stability programs, comparability assessments, etc.) across development is required