PD Director – San Diego or LA based – Onsite
My client is a biotechnology company focused on developing innovative cancer immunotherapies, with a primary focus on genetically engineered autologous CAR T cell therapies. We aim to improve patient outcomes through transformative cell-based therapies.
Position Summary:
The Process Development Director will lead the development and optimization of processes for autologous CAR T cell therapies. This role involves overseeing the scaling of cell-based therapies from preclinical to commercial manufacturing, ensuring regulatory compliance, and driving continuous improvement efforts.
Key Responsibilities:
- Leadership & Strategy: Lead the process development team, aligning goals with company strategy and ensuring milestone delivery.
- Process Development: Develop, optimize, and scale-up CAR T cell manufacturing processes (cell culture, genetic modification, expansion, and purification).
- Collaboration: Work with R&D, quality, regulatory, and clinical teams to ensure smooth translation from development to clinical/commercial manufacturing.
- Regulatory Compliance: Ensure all processes comply with GMP and regulatory guidelines (FDA, EMA) and support IND/BLA filings.
- Team Management: Build, mentor, and manage a high-performing process development team.
- Continuous Improvement: Identify and implement process improvements to optimize yield, cost, and timelines.
Qualifications:
- Education: Ph.D. or M.S. in Biotechnology, Immunology, Bioengineering, or related field.
- Experience: Minimum 10 years in biotechnology with at least 5 years in a leadership role in process development, specifically for cell-based therapies like CAR T.
- Skills: Expertise in CAR T cell process development, gene editing, and GMP. Strong leadership, communication, and problem-solving abilities.
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