Director, Preservation Media Development

The Director of Preservation Media Development will lead the development and optimization of innovative preservation solutions for cells, organoids, and related starting materials for regenerative medicine. This role requires a deep understanding of cryobiology, cell culture, and biopreservation techniques, as well as experience in developing products from conception through commercialization. You will own the short-, medium-, and long-term roadmap that will deliver a core media product and the ability to modify it to support new cell types. The successful candidate will collaborate with cross-functional teams, including Product Management, Operations, Quality, Regulatory Affairs and Business Development to ensure successful launches of category-defining products.

Duties and Responsibilities

• Lead and manage the R&D team in the rational design, development, and optimization of cell preservation media formulations
• Oversee the planning and execution of experimental studies to evaluate the mechanism of action of preservation media formulations
• Coordinate internal and external resources to deliver formulations that meet requirements in the required timeline
• Collaborate with cross-functional teams evaluate trade-offs, in terms of performance, manufacturability and cost
• Develop the analytical framework necessary for high throughput experimentation
• Stay abreast of scientific advancements and industry trends to drive innovation and maintain a competitive edge
• Collaborate with Operations on the creation of GMP procedures and records.
• Ensure compliance with relevant regulatory standards and guidelines throughout the product development process.
• Mentor and develop team members, fostering a culture of scientific excellence and continuous improvement.

Education and Work Experience

• Ph.D. in Cell Biology, Biochemistry, Biomedical Engineering, Chemistry, or a related field.
• A minimum of 5 years’ hands-on industry experience developing chemical solutions.
• A minimum of 10 years of experience in biopreservation, cryobiology, cell manufacturing or related areas, with at least 5 years in a leadership role.
• Proven track record of developing and commercializing cell preservation media or related bioprocessing products.
• In-depth knowledge of cell culture techniques, cryopreservation principles, and analytical techniques.
• Familiarity with cGMP, GLP, and regulatory requirements for biological products.
• Working knowledge of metabolomics and Cell Therapy manufacturing
• Knowledge of ISO13485 is an asset.

Skills Required:

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across disciplines.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Demonstrates a sense of urgency, strong work ethic and a “can do” attitude.
• Willingness to take on challenges and view changes as opportunities.

CryoStasis has developed a combination of media and instrumentation that enables cell preservation without freezing. This highly innovative approach to biopreservation unlocks scalable fill/finish, ensures consistent potency from bioreactor to bedside and drives significant CGT manufacturing efficiencies.

We believe CryoStasis is positioned to have significant impact on CGT manufacturing, and biopreservation broadly speaking. The Director of Preservation Media Development will be a significant contributor to that impact.

You bring the experience to lead an R&D team into unmapped territory, and the experience to understand that the only way forward is with a tight-knit, highly collaborative group. You thrive in fast-paced, high-impact environments. You have great judgement and effective communication skills. You’re also a self-directed, efficient multitasker with a startup mindset. Does the shoe fit? Get in touch!

CryoStasis is an inclusive employer in every way, and we are committed to providing accommodation for people with disabilities. If you require accommodation, please notify the hiring manager and we will work with you to mutually address your needs