Senior Consultant, Nanoparticle Formulation and CMC

Genedit - South San Francisco, CA

Part-time - Senior

South San Francisco, CA

Chemical Manufacturing

About the position

GenEdit is a rapidly growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload, formulation, screening, and preclinical groups to develop the next generation of gene therapies. GenEdit fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from platform technology to a pipeline of therapeutic candidates. We are seeking talented and motivated individuals to join our team and be at the forefront of gene delivery and therapy. We are seeking a Senior Consultant of Nanoparticle Formulation and CMC to join our cross-functional discovery teams and create transformative therapeutic drug candidates. While this position will be part-time to start, there is the potential to transition to full-time.

Responsibilities

• Support and lead formulation research activities related to the scale-up and downstream process development of GenEdit's hydrophilic nanoparticle (HNP) therapeutic drug candidates.
• Establish optimized methods of preformulation and payload encapsulation, purification, concentration, sterile filtration, and long-term storage.
• Refine existing HNP analytical characterization and expand internal QA/QC capabilities.
• Develop strategy and design studies, troubleshoot technical issues, support drug product manufacturing activities, and provide technical SME advice for all phases of formulation development.
• Collaborate with cross-functional teams including polymer chemists, molecular and cell biologists, and in vivo scientists to address critical CMC issues and meet product development and regulatory filing milestones.
• Oversee CDMO selection and management.
• Prepare and review CMC documentation for regulatory submissions (IND, BDA, BLA) and ensure efficient technology transfer activities to external manufacturing sites.
• Address questions from regulatory agencies and ensure compliance with global regulatory standards.
• Ensure adherence to timelines, budgets, and quality standards.
• Identify and mitigate CMC-related risks and develop robust risk management strategies to ensure project success.

Requirements

• PhD degree in nanoscience, gene therapy, gene delivery or a closely related discipline with a minimum of 10 years in the pharmaceutical or biotech industry.
• Knowledge of drug product development lifecycle for biologics focused on RNA therapeutics and nanoparticle delivery technologies.
• Extensive experience with drug product formulation from research through preclinical PoC and clinical development.
• Direct experience working with polymeric nanoparticles, PLGA-PEG, LNP, and lipoplex for nucleic acid delivery.
• In-depth knowledge of nanoparticle rapid-mixing formulation techniques (e.g., T-junction, IJM, microfluidic, SHM).
• Proficiency in nanoparticle characterization techniques (e.g., DLS, MALS, SLS, encapsulation efficiency, CE, NTA, TEM).
• Proficiency in nanoparticle PD (e.g., TFF, UF/DF, sterile filtration, stability excipient screening and testing, cryopreservation, and lyophilization).
• Familiarity with regulatory requirements and guidelines for drug product formulation, including cGMP and ICH guidelines.

Nice-to-haves

• Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation.
• Ability to build strong relationships and collaborate effectively with other interfacing GenEdit functions.
• Comfortable challenging the status quo and bringing forward innovative solutions.
• Ability to take risks implementing innovative solutions.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
• Excellent written and verbal communication skills in English.