Director, Cell Engineering & Manufacturing Sciences

Bio Talent are partnered with an emerging stealth mode biotech company developing next-generation engineered cell therapies to search for a Director, Cell Engineering & Manufacturing Sciences.

You will lead the translation of complex cell engineering workflows into GMP-compatible manufacturing processes.

This is a unique opportunity to join a highly entrepreneurial team at an early stage and play a pivotal role in building the company's cell engineering and manufacturing capabilities from the ground up. The successful candidate will combine deep expertise in genome engineering and cell biology with a strong understanding of process development, technology transfer, and external manufacturing strategy.

• Lead cell engineering activities across the company's therapeutic platform, including genome editing, clone selection, characterization, and cell banking strategies.
• Develop scalable, GMP-compatible processes that support progression from research through clinical manufacturing.
• Serve as the technical lead for external manufacturing activities, partnering closely with CDMOs, CROs, and analytical testing providers.
• Drive process transfer, manufacturing readiness, comparability assessments, and technical oversight of outsourced development and production activities.
• Define genomic characterization and quality strategies to support product development and regulatory expectations.
• Collaborate with Quality, Regulatory, CMC, and Process Development teams to establish specifications, documentation, and clinical-stage manufacturing plans.
• Help build the organization's technical infrastructure, capabilities, and future team as the company grows.

• PhD / MSc / Degree in Biotechnology, Biochemical Engineering, Cell Biology, Stem Cell Biology, Genetics, Molecular Biology, Bioengineering, or a related discipline.
• Significant industry experience within cell therapy, regenerative medicine, gene editing, or advanced biologics.
• Deep expertise in CRISPR-based genome engineering and engineered cell systems.
• Experience developing or transferring processes into GMP manufacturing environments.
• Strong understanding of technology transfer, CDMO management, process development, and CMC activities.
• Familiarity with genomic characterization methodologies and product quality considerations.
• Working knowledge of FDA and global regulatory expectations for cell and gene therapy products.
• Comfortable operating in a fast-paced startup environment with a hands‑on and highly autonomous approach.

This role is ideal for a technically accomplished scientist who enjoys building from scratch, wearing multiple hats, and bridging the gap between research innovation and clinical manufacturing. The successful candidate will possess both scientific depth and operational pragmatism, with the ability to lead externally, influence cross‑functional stakeholders, and establish the foundation for future growth.

For a confidential discussion, please get in touch directly.