Promethera® Biosciences is a global innovator in liver therapeutics whose mission is to bring patients life-saving treatments to reduce the need for liver transplantation. Our lead clinical program, derived from our patented cell technology platform HepaStem™, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline, we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.
If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 150 people, consider a collaboration with our fast-growing company. Promethera® Biosciences is currently hiring a VP, CMC Cell Therapy
DESCRIPTION OF THE POSITION
The VP CMC is accountable for leading the CMC development activities for global filing and approval of different phases cell-therapy products and prepare commercialization. The VP CMC will report to the COO and will interact with different departments and senior leadership across Promethera Biosciences together with external collaborators. To be successful in this role, the ideal candidate must have, extensive product development expertise in biotechnology or cell and gene therapy areas, regulatory and compliance awareness, strategic thinking, as well as excellent leadership and influencing skills.
- Lead a Cell Therapy CMC team to deliver early and late-stage CMC development strategies for Cell Therapy products.
- Lead all CMC activities required for successful, on-time global regulatory filings.
- Define CMC goals, milestones and timelines for the team, coordinate and monitor progress, and manage team activities to ensure successful implementation of the endorsed development strategy.
- Represent the CMC team in program reviews with governance boards and senior management.
- Escalate issues and risks and recommend risk mitigation strategies according to governance procedures.
- Stay abreast of evolving global regulations and industry practices for the development and approval of Cell Therapy products worldwide.
- Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed. Provide input into the performance reviews of team members.
- Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies.
- 10 years of experience in biotech or cell and gene therapy with exposure to all stages of product development.
- Proven record of successful leadership of CMC development teams.
- Highly developed interpersonal and communication skills.
- Demonstrated ability to influence and effectively align, motivate and empower the team to progress project goals in a fast-paced environment.
- Proven ability to work effectively with cross-functional leaders in a complex/changing global environment.
- Subject-matter expertise to strategically lead the CMC team towards its goals
- Demonstrated experience in preparing and executing complex strategic plans and balancing competing priorities.
- Strong problem-solving and risk-based decision-making skills
- Demonstrated ability for critical and strategic thinking
- At our headquarters in Mont-Saint-Guibert / Gosselies, Belgium
You may apply for this position by sending your CV and application letter to email@example.com
Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.