Principal Scientist, Cell Therapy Process Development

Description

JOB TITLE: Principal Scientist, Cell Therapy Process Development

LOCATION: Cambridge, MA

REPORTS TO: Senior Director, Cellular Therapeutics and Process Development

SALARY RANGE: $172,000 to $187,000

ABOUT THE POSITION

The Principal Scientist, Cell Therapy Process Development position plays a key role in implementing and optimizing processes related to the development of cellular therapies involving primary cells and stem cells. This individual will work independently to optimize cell culture manufacturing process using Quality by Design principle and multivariate approaches. This position will develop and integrate cell culture platforms into a GMP compliant workflow for late-stage development. We are seeking an individual with the breadth of professional experience and drive to work effectively with both internal and external partners in a highly matrixed and cross-functional organization.

KEY RESPONSIBILITIES

• Responsible for development and optimization of cellular therapy manufacturing process involving primary mammalian cells and stem cells
• Perform process development studies by implementing Design of Experiment approaches, and statistical analysis to make data driven decisions around implementation of new materials or process.
• Develop, optimize and refine cell manufacturing processes for clinical and commercial manufacturing.
• Proactively pursues experience with later development stages of cell manufacturing processes for clinical and commercial manufacturing.
• Heavily supports technology transfers and quality documents, regulatory filings, interactions with CMOs and CROs.
• Participates in internal and external collaborations to evaluate and implement new process technologies.
• Maintains up to date knowledge of cell therapy manufacturing trends and provides recommendations regarding manufacturing process improvement initiatives.
• Authoring of SOPs, protocols, technical reports, regulatory documents.
• Complies with all applicable laws and Company policies regarding health, safety, innovation and environment.

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.

• PhD in a scientific discipline with 8+ years of relevant industry experience or a Master’s degree with 10+ years of relevant industry experience.
• Process Development experience with cell therapy programs highly preferred.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Strong experience in cell therapy process development using multivariate studies using Quality by Design principles.
• Experience with JMP software or equivalent. 
• Demonstrated cell production technology development experience in a cell therapy setting.
• Must have strong initiative and drive to complete challenging tasks and learn new technologies.
• Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
• Demonstrated experience working effectively with both independently and with other interdisciplinary and cross-cultural team of scientists, engineers, quality and regulatory specialists, and business professionals.
• Intermediate proficiency of MS Office products.