Job Details

GenEdit is a rapidly-growing, early-stage company developing a proprietary delivery platform with the potential to transform genetic medicine. Our interdisciplinary team collaborates across chemistry, payload design, formulation, and screening to develop next-generation gene therapies. We foster an innovative environment that values impactful data and creative solutions to advance from platform technology to therapeutic candidates. Join us in South San Francisco, CA, to be at the forefront of gene therapy innovation.

Senior Consultant, CMC Development and Manufacturing

We seek a leader to provide technical and organizational guidance, working closely with cross-functional stakeholders to ensure seamless execution of CMC activities aligned with development plans and timelines. The role involves managing manufacturing of drug substances and products for late-phase trials, contributing to CMC strategy, preparing regulatory documentation, and overseeing CDMO management across analytical and drug product areas.

The candidate will be a key member of the R&D management team, involved in planning and executing company objectives and R&D strategies. The ideal individual is a strong scientist with proven technical expertise, leadership experience, and knowledge of the drug discovery process from research to IND submission. They should be able to guide project teams, solve complex problems, and operate effectively in a startup environment, collaborating across functions and with external partners.

Responsibilities

1. Lead polymer synthesis, development, and manufacturing to support the pipeline.
2. Manage project timelines for CMC activities supporting clinical trials, ensuring alignment with company goals.
3. Oversee in-house CMC personnel and external experts.
4. Lead vendor identification, assessment, qualification, and management, including risk assessment.
5. Manage tech transfer, process familiarization, and manufacturing at CDMOs to ensure timely GMP delivery.
6. Negotiate contracts and quality agreements.
7. Implement a QBD approach to identify CPPs and support CQAs for efficacy and safety.
8. Author, review, and approve CMC sections for regulatory filings.
9. Review study protocols, reports, and batch records.
10. Manage analytical activities appropriate to development stages.
11. Communicate CMC strategies and project status to stakeholders and support decision-making.
12. Collaborate with clinical development, regulatory, quality, and IP teams to meet program goals.

Qualifications

• PhD in polymer chemistry, polymer science, or engineering with industry experience in synthesis scale-up and downstream processing, preferably in therapeutics.
• 10+ years in industry CMC; 3+ years leading teams and projects.
• Proven vendor management skills, especially with CDMOs, including contract negotiation and project delivery.
• Experience managing GMP manufacturing for late-phase trials.
• Deep understanding of drug substance development, quality by design, GMP, ICH guidelines, FDA, EMA regulations; NDA writing experience is a plus.
• Proficiency with analytical techniques such as NMR, GPC-RI, HPLC, UV-vis, fluorescence spectroscopy, DSC, ITC, MAL-SEC.
• Motivated scientist with strong attention to detail, capable of independent experimental planning and execution.
• Excellent communication and presentation skills.
• Work authorization in the US is required.

At GenEdit, we value diversity and are committed to inclusive hiring practices. We welcome candidates of any race, color, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, or any other characteristic, as these differences strengthen our team and our mission.