Vice President of Product Development
Miromatrix is a biotechnology company on a mission to save and drastically improve countless lives by eliminating the organ transplant waiting list. Through our proprietary perfusion decellularization and recellularization technology, we are bioengineering human livers and kidneys to solve the large unmet clinical need that exits today. Our decellularization technology has been used to manufacture our commercialized liver-derived soft tissue reinforcement, MIROMESH®, and advanced wound care, MIRODERM® products, and will provide the foundation for our advanced whole-organ products.
Miromatrix is seeking a highly motivated individual to join our team as the Vice President of Product Development (VPD) at our facility in Eden Prairie, MN. Reporting to the CEO, the VPD will lead the company's programs to develop and commercialize bioengineered transplantable livers and kidneys. The position involves research with a larger emphasis on product development.
This individual will be responsible for the technical development of our whole organ programs to support our IND submissions. The VPD will work closely with the CEO, Clinical, Manufacturing, Quality and Regulatory functions to support the development and commercialization of whole organs for transplant. Responsibilities also include championing processes that focus on the leadership and development of employees who support department projects.
The specific responsibilities of this position include:
Be an active member of the Senior Management team with responsibility for assisting the CEO in developing and implementing the Company's research and development strategy
Drive and direct development and validation activities to enable successful pre-IND and IND approvals
Lead the design of in vitro and in vivo studies for the validation of the whole organ function and the interpretation, publication, presentation and support for those product findings
Interact with and present to the Scientific Advisor Board (SAB)
Work with process development and technical operations teams to evaluate opportunities to optimize the manufacturing processes through cell banking and whole organ cell acquisitions
Responsible for multiple projects, developing and orchestrating timelines and meeting deadlines to achieve company's goals and milestones
Ensure compliance with appropriate process development, QA/QC requirements and other standards of highest quality research performance, including laboratory safety, animal care and workplace management regulations
Develop and manage a budget for internal and external research activities
Manage a network of external experts and foster excellence in work and partnership
Lead and mentor a team of talented scientists and laboratory professionals
Contribute to publication and Intellectual Property efforts around the company's novel technologies, tools and scientific insight
M.S., M.D. or Ph.D. in Biology, Cell Biology, Molecular Biology, Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of ten (10) years of biotech or device industrial experience
Experience with cellular, tissue-based and biologic programs, from early-stage through validation and commercialization
Well versed in cellular and tissue-based manufacturing process technologies
Experience in complex issues where data/DOE (design of experiments) requires an in-depth knowledge of product/ process development and engineering
Solid understanding of current FDA guidelines and regulatory expectations
CMC background in biologics
Specific knowledge and in-depth understanding of process and product development as evidenced by a track record of significant contributions to successful IND and/or BLA submissions
At least eight (8) years of direct people management experience including, training, coaching, and developing a team, driving employee engagement, and providing motivation to accomplish goals and objectives
Excellent verbal and written communication skills, and the ability to influence and interface effectively with internal and external stakeholders
Experience in managing budgets, project timelines, and resources to accomplish company objectives
Miromatrix is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, and any other characteristic protected by law.