Director, Genome Engineering & Manufacturing Sciences

BioTalent; San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

BioTalent seeks a Director, Genome Engineering & Manufacturing Sciences to lead genome engineering workflows and translate them into GMP-ready manufacturing processes for a next-generation cell therapy platform.

The role combines deep scientific expertise with hands-on process development, tech transfer, and external manufacturing strategy, shaping the company’s biology-to-manufacturing capability from inception in California.

Qualifications

• PhD or MSc in biotechnology or a related discipline.
• Significant industry experience in cell therapy, regenerative medicine, gene editing, or advanced biologics.
• Deep expertise in CRISPR-based genome engineering and engineered cell systems.

Responsibilities

• Lead genome engineering activities across the therapeutic platform, including editing, clone selection, characterization, and cell banking.
• Develop scalable, GMP-friendly processes supporting transition from research to clinical manufacturing.
• Act as technical lead for external manufacturing activities with CDMOs and CROs.
• Drive process transfer, readiness assessments, and oversight of outsourced development and production.
• Define genomic characterization and quality strategies aligned with regulatory expectations.
• Collaborate with Quality, Regulatory, CMC and Process Development to establish specs and documentation.

Skills

CRISPR genome engineering

Process development

Technology transfer

CDMO management

Regulatory understanding

Cell biology

Genomics characterization

Education

PhD in Biotechnology or related field

MSc in related discipline

Job description

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

You will lead the translation of complex genome and 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.

Key Responsibilities

• Lead genome 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.

Ideal Background

• 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.

Who We're Looking For

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.

Location

Location: California preferred (Bay Area or Los Angeles)