CMC Director, RNA therapeutics

Build the future of RNA therapeutics with us

At Oragen Therapeutics, we're rethinking how RNA drugs are delivered. Our ambition is to make oral RNA therapies a reality.

As we accelerate towards clinical development, we are looking for a Director of CMC Development to lead and execute our CMC and industrialization strategy.

Your mission

You will define and drive the CMC development and manufacturing strategy of our pipeline, ensuring efficient, scalable, and regulatory-compliant progression from candidate selection to clinical manufacturing and beyond.

You will play a critical leadership role at the interface of science, manufacturing, quality, regulatory affairs, and external partners.

What you’ll do

• Define and implement the overall CMC development strategy for Oragen's siRNA therapeutic programs
• Define and drive CMC activities of the selected oligonucleotide and LNP-based drug candidates including process development, analytical development, and manufacturing readiness
• Establish industrialization plans for oligonucleotide and LNP-based drug candidates, from development through clinical manufacturing
• Contribute to development decision-making at project and company level

Process Development & Industrialization

• Define and lead, in collaboration with the research team, analytical development, manufacturing process development, and scale-up strategies for oligonucleotide- and LNP-based drug candidates, ensuring robust, reproducible, and scalable manufacturing processes.
• Select, engage, and manage CDMOs for the analytical and manufacturing development including formulation of the drug candidates as well as for the GMP production, analytical validation and clinical supply.
• Identify technical risks and implement mitigation plans throughout development
• Ensure efficient transfer of processes from research to GMP manufacturing

CDMOs & External Partner Management

• Act as the primary scientific and operational point of contact for external manufacturing activities
• Oversee project timelines, budgets, deliverables, and quality standards
• Build long-term partnerships to support the company's growth and clinical ambitions

Regulatory & CMC Documentation

• Lead the preparation, review, and maintenance of CMC documentation supporting regulatory submissions from the CDMOs
• Author and/or coordinate relevant sections of IND/CTA dossiers (module 3) and briefing documents with the support of CDMOs
• Ensure compliance with regulatory expectations and applicable GMP standards
• Support interactions with regulatory agencies on CMC-related topics

Program Execution & Cross-Functional Collaboration

• Coordinate CMC activities across internal and external stakeholders
• Ensure alignment between research, non-clinical, clinical, quality, and regulatory functions
• Drive programs towards key development and clinical milestones
• Support budget planning, resource allocation, and operational execution

Who you are

Education & Experience

• PhD, PharmD, MSc, or equivalent in pharmaceutical sciences, chemistry, biotechnology, chemical engineering, or related field
• 10+ years of experience in CMC development within biotech, pharma, or CDMO environments
• Proven track record of advancing drug candidates into clinical development
• Experience with lipid nanoparticle (LNP) formulation development and manufacturing
• Experience with oligonucleotide therapeutics (siRNA preferred) is a plus
• Hands-on experience managing external manufacturing and development partners
• Solid understanding of GMP requirements and regulatory CMC expectations
• Fluency in both French and English

Mindset

• Strategic thinker with a hands-on attitude
• Comfortable in a fast-paced, startup environment
• High level of ownership and accountability
• Collaborative, pragmatic, and results-driven
• Strong problem-solving skills and ability to navigate ambiguity
• A dynamic, fast-growing environment
• A company where your voice matters and you can make a real impact
• The opportunity to contribute to a breakthrough technology and new class of therapeutics
• Collaboration with leading experts and international teams
• Great work-life balance: 5 weeks of paid leave + up to 10 additional days off per year.

Location: Besancon or Lyon (France) greener than Paris and way more affordable.

Partial remote work is possible

Equal Opportunity Employer

Oragen Therapeutics is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability status.