Scientist II, Analytical Development

Aurion Biotech, Inc.; Cambridge (MA); On-site; USD 140,000 - 155,000; Full time

Job summary

Aurion Biotech, Inc. in Cambridge, MA, is seeking a Scientist II, Analytical Development to join a multidisciplinary team supporting in-process control, characterization, and release assays for late-stage cell therapy manufacturing.

You will help qualify and transfer methods to GMP, collaborate with Research, Process Development, and Quality, and ensure assays meet regulatory timelines. A PhD with 2+ years or MS with 4+ years in relevant fields is required.

Qualifications

• PhD with 2+ years or MS with 4+ years in immunology/biochemistry/cell biology/biotechnology or related field.

Responsibilities

• Perform independent lab experiments (Flow Cytometry, cell counting, dPCR, qPCR, ELISA, potency assays).
• Collaborate cross-functionally with Cell Production, Process Development, Manufacturing, and Quality.
• Support method qualification SOPs, qualification reports, and test method SOPs for regulatory submissions.
• Track progress toward milestones and ensure deliverables are met.
• Support development, qualification, and transfer of GMP-compliant analytical methods.
• Experience with QC and regulatory requirements for late-stage development preferred.
• Other duties as assigned.

Skills

Analytical method development

Cell therapy knowledge

Regulatory understanding

Cross-functional collaboration

Education

PhD + 2+ years

MS + 4+ years

Tools

FlowJo

JMP

GraphPad Prism

Job description

Description

JOB TITLE: Scientist II, Analytical Development

LOCATION: Cambridge, MA

SALARY RANGE: $140,000 to $155,000

ABOUT THE POSITION

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.

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.
• 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.

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 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, 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.