Scientist II, Analytical Development

Description

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. 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.

• 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.
• Support the authoring of 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.
• 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 are highly preferred.
• Other duties as assigned.

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

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

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…