Join Our Crew

Responsibilities Include

• Develop and execute the overall MDS&T strategy for cell therapy products, aligning it with the company's objectives and growth plans.
• Provide leadership and direction to cross-functional teams, fostering collaboration, and driving process innovation.
• Drive technology transfer planning and execution across manufacturing network.
• Ensure the scalability and robustness of processes to meet commercial production requirements.
• Maintain a deep understanding of relevant regulatory guidelines and ensure that all process development activities adhere to regulatory standards (e.g., FDA, EMA).
• Collaborate with regulatory affairs to support submissions and inspections.
• Build a best-in-class MDS&T team through recruitment, mentoring, and managing a team high-performing team of scientists and engineers in process development.
• Set clear objectives, provide guidance, and foster professional development.
• Facilitate the successful transfer of processes from development to manufacturing teams, ensuring seamless scale-up and technology transfer activities.
• Collaborate with cross-functional teams, including manufacturing, quality, research, and clinical development, to achieve project milestones and goals.
• Communicate progress and findings to senior leadership and stakeholders.
• Manage the budget and allocate resources efficiently to support process development projects.
• Ensure cost-effective strategies while maintaining quality standards.
• Identify potential risks in the development process and implement mitigation strategies to ensure product success and patient safety.
• Drive a culture of continuous improvement, implementing new technologies and best practices to enhance process efficiency and product quality.

Required Qualifications

• M.S. or equivalent in bioengineering or a relevant scientific discipline (e.g., cell biology, biotechnology).
• 15+ years’ experience in process development within the cell therapy industry.
• Strong knowledge of cell therapy manufacturing processes, including cell culture, cell expansion, gene editing, and downstream processing.
• Proven leadership and team management skills, with a track record of building and leading high-performing teams.
• Deep understanding of cGMP regulations and experience in regulatory interactions and submissions.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Results-oriented mindset with a focus on achieving project goals and timelines.
• Strong problem-solving skills and the ability to adapt to changing priorities in a dynamic environment.
• Experience in technology transfer and process scale-up is a plus.

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