Scientist II, Analytical Development

Aurion Biotech is seeking a highly motivated Scientist II, Analytical Development in Cambridge, MA. This position will serve as an integral part of a multidisciplinary team to support the development, qualification, and transfer of in-process control, characterization, and release assays to support late-stage clinical manufacturing and testing of cell therapy products.

About the role

The individual in this role will work collaboratively with the Research, Process Development, Quality, and other groups to ensure assays meet the timeline of characterization and release of cell therapy products.

Responsibilities

• Conduct various independent laboratory experiments including but not limited to Flow Cytometry, cell counting, dPCR, qPCR, ELISA, and cell-based potency assays to satisfy overall Analytical Development objectives.
• Collaborate cross-functionally with other functions including Cell Production, Process Development, Manufacturing, and Quality.
• Support the authoring of method qualification SOPs, method qualification reports, test method SOPs, and other technical documents to support regulatory submissions and other groups.
• Track progress toward project milestones and ensure that deliverables are met.
• Support 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.
• Experience with Quality Control and regulatory requirements for late-stage method development and documentation is highly preferred.
• Other duties as assigned.

Requirements

• A PhD with 2+ years of experience or an MS degree and 4+ years of experience in a relevant discipline (immunology, biochemistry, cell biology, biotechnology, or related field) in the pharmaceutical industry and academia, specifically in gene and cell therapy.
• Experience with biological therapeutic products is critical; experience specifically with cell therapy technologies is preferred.
• 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.

Skills

• Ability to work in a dynamic, fast-paced, matrix environment, manage priorities, and maintain timelines for multiple projects.
• Demonstrated ability to technically troubleshoot 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.
• Ability to work both independently and in a matrix team environment.
• Strong interpersonal and communication skills; must be a team player and 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 characterization.
• Familiarity with data analytics software such as FlowJo, JMP, and GraphPad Prism.

Pay

$140,000 to $155,000

Benefits

• Full health insurance for employees and their families.
• 401(k) matching.
• Employee Assistance Program (EAP).
• Flexible Spending Account (FSA).
• Generous PTO.
• Competitive compensation packages.
• Paid parking and subsidized commuter passes.
• In-office catered lunches.
• Team events and community projects.

About Aurion Biotech

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction and is one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S.

Aurion Biotech values include:

• Stewardship: Making the world a better place for patients, communities, clinicians, and colleagues by acting responsibly as individuals, employees, and as a company.
• Transformation: Embracing challenges, successes, and failures with curiosity, risk-taking, and collaboration.
• Grit: Breaking down walls and striving to achieve the impossible through persistence, resilience, and delivering on commitments.

Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care.