Scientist II, Process Sciences at Aurion Biotech

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Jul, 26

Salary

123000.0

Posted On

15 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mammalian cell culture, Cellular metabolism, Statistical analysis, Process development, GMP manufacturing, Tech transfer, Data analysis, Root cause analysis, Process characterization, Regulatory compliance, JMP, GraphPad Prism, Technical writing, Cross-functional leadership, Cell therapy, Biologics

Industry

Biotechnology

Description

Description JOB TITLE: Scientist II, Process Sciences LOCATION: Cambridge, MA SALARY RANGE: $112,000 to $123,000 ABOUT THE POSITION Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and it is advancing into Phase 3 clinical trials in 2025. Aurion operates as a separate entity with full support from Alcon. This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. The role of Scientist II, Process Sciences deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The Scientist II, Process Sciences may support all phases of projects from research and feasibility studies through implementation into commercial manufacturing processes. The ideal candidate will be proficient with mammalian cell culture and have a solid understanding of cellular metabolism. This is a great opportunity for candidates who are curious, have a love for learning, and an ability to collaborate with diverse thought backgrounds while adapting quickly to new information. The Scientist II, Process Sciences should be someone who continuously drives to improve processes for optimized performance while working on multiple independent and group projects simultaneously. KEY RESPONSIBILITIES Analyze large data sets from Process Development and manufacturing data using a combination of statistics, scientific principles and other techniques to gain insights into process performance to build conclusions related to process capability and understanding Lead Cross-functional teams to Investigate non-conformance results from the program risk registers to identify root causes and recommend corrective actions Create presentations to communicate findings and influence decision-making Author/ maintain technical reports and tech transfer documents to support GMP manufacturing processes Lead and collaborate with cross functional teams to drive continuous improvement in manufacturing Collaborate with development team on process characterization study design and outputs to comply with regulatory standards. May act as subject matter expert on cell process during non-conformance investigations and tech transfer Work effectively and efficiently in a team-oriented environment. Expected to interact and collaborate cross-departmentally Complete appropriate GxP training, when needed Other duties as assigned 10% travel expected; onsite in Cambridge office for first year required 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 full-time 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. Bachelor’s degree in a scientific discipline (Biology, Chemistry, Engineering, or related field). 5+ years of experience in the pharmaceutical or biotechnology industry within a GMP environment Experience in tech transfer, scale-up, and cell therapy/biologics processes highly preferred Proficiency in mammalian cell culture required Hands-on experience with statistical analysis software required (JMP, GraphPad Prism, or equivalent)

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Responsibilities

The Scientist II will analyze large data sets to optimize process performance and lead cross-functional teams in investigating non-conformance results. They will also author technical reports and collaborate on process characterization studies to ensure regulatory compliance.