Product Manager Cell & Gene Therapy Development
Job Summary
: We are looking for a visionary Product Manager to spearhead the development of innovative products for our Cell & Gene Therapy portfolio. This role will focus on designing and advancing novel therapeutic solutions, from initial concept through preclinical and early clinical stages, in close partnership with R&D, clinical, and manufacturing teams. The ideal candidate brings expertise in cell and gene therapy, a knack for translating scientific potential into viable products, and a drive to deliver life-changing treatments to patients.
Key Responsibilities
: - Product Concept Development: Identify opportunities for new cell and gene therapy products by analyzing scientific advancements, patient needs, and market gaps; define product concepts and initial specifications.
- Development Strategy: Create and manage the development roadmap for new therapies, prioritizing projects based on scientific feasibility, therapeutic impact, and business potential.
- Scientific Collaboration: Work hand-in-hand with R&D teams to design and refine cell and gene therapy products (e.g., CAR-T, gene editing, viral vectors), ensuring alignment with cutting-edge science.
- Process Integration: Partner with manufacturing and process development teams to embed scalability, reproducibility, and quality into product design during early development phases.
- Clinical Transition: Support the transition of products into clinical development by defining target indications, patient profiles, and early-stage trial requirements with clinical teams.
- Market Alignment: Conduct competitive analysis and stakeholder research (e.g., clinicians, payers) to ensure new products meet market demands and deliver differentiated value.
- Risk Management: Assess and mitigate risks related to technical challenges, regulatory hurdles, and development timelines, adapting plans to maintain progress.
- Cross-Functional Coordination: Act as the central point of contact across teams R&D, regulatory, quality, and commercial to drive cohesive product development efforts.
- Innovation Advocacy: Champion emerging technologies and methodologies (e.g., next-gen vectors, delivery systems) to enhance the cell and gene therapy product pipeline.
Qualifications:
- Education: MS, PhD, MBA in Lifesciences/Biotechnology, Bioengineering
- Experience:5+ years of product management or development experience in biotech/pharma, with at least 2 years directly involved in developing cell and/or gene therapy products.
- Technical Knowledge: In-depth understanding of cell and gene therapy development, including cellular engineering (e.g., T-cell therapies), gene editing (e.g., CRISPR), and vector design (e.g., AAV, lentivirus).
Skills:
Strong ability to bridge scientific innovation with practical product outcomes. Experience managing complex, multi-disciplinary projects in a fast-paced environment. Excellent problem-solving and decision-making skills under uncertainty. Clear communication skills for technical and non-technical audiences.
Preferred
: Background in oncology, rare diseases, or regenerative medicine; experience with CMC or early-stage regulatory submissions.