Senior Scientist, Analytical Development at Aurion Biotech

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

170000.0

Posted On

11 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Flow Cytometry, dPCR, qPCR, ELISA, Cell-based Potency Assays, Analytical Method Development, Method Qualification, GMP Compliance, Cell Therapy, Regulatory Submissions, Technical Troubleshooting, FlowJo, JMP, GraphPad Prism, Biologics Analytics, Cross-functional Collaboration

Industry

Biotechnology

Description

Description JOB TITLE: Senior Scientist, Analytical Development LOCATION: Cambridge, MA SALARY RANGE: $155,000 to $170,000 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. 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. 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 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. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values: Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company. Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments. Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com LIFE AT AURION BIOTECH We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding: Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO. Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work. Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values. Requirements 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 3-5 years’ experience or an MS degree and 6-8 years of 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 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. 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 characterization. Familiar with data analytics software such as FlowJo, JMP, and GraphPad Prism.

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Responsibilities

Develop, qualify, and transfer in-process control and release assays to support clinical manufacturing of cell therapy products. Collaborate cross-functionally to author technical documents and ensure assays meet regulatory requirements for FDA and EU submissions.