Director, Drug Product Development

The job overview for the Director, Drug Product Development role at Scribe Therapeutics is to lead and build a team focused on the development and optimization of drug products for CRISPR-based therapeutics. The candidate will be responsible for the formulation and characterization of delivery vehicles, specifically lipid-based nanoparticles, as well as the design and execution of experiments to understand their mechanism of delivery. Additionally, the candidate will guide Scribe's nanoparticle delivery strategy, manage interactions with internal and external partners, and oversee tech transfer and coordination with contract manufacturing organizations. The ideal candidate should have a PhD with 8+ years of relevant industrial experience and a background in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Biochemistry, or a related field.

• Building and leading a team of research specialists and scientists in the Drug Product Process Development Group with focus on LNP production, process development, and physicochemical characterization; with the potential to also work on AAV drug product development.
• Establishing methods to support high-throughput LNP formulation development to enable screening new CRISPR technologies and build a robust, scalable process to clinical production.
• Managing a core function of the team to produce, physiochemically characterize, and optimize LNP production.
• Being responsible for the development and characterization of novel delivery vehicles (lipid based, polymer based, or a hybrid of the two) as well as building the assay toolbox to understand the principles behind their delivery mechanism.
• Development and execution of cell-based and cell-free assays to understand structure-activity and structure-function of our delivery systems.
• Designing and executing experiments that elucidate the mechanism of LNP delivery to various tissues and cell types.
• Guiding Scribe’s nanoparticle delivery strategy, with a particular emphasis on IP and key deliverables.
• Managing interactions across the company and with external partners on behalf of the team to ensure alignment of the team’s activity with company priorities. (specifically with Quality, Regulatory, Supply Chain, Process Development, Analytical to build consensus on key issues and facilitate decision making to move the project forward)
• Leading tech transfer, and coordination of contract manufacturing organizations (CMOs) for GxP material supply.

• PhD with 8+ years of relevant industrial experience in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Biochemistry, or related field preferred
• Track record of understanding and experience with nucleic acid-LNP formulation
• General understanding of chemistry and structure activity relationships of LNP lipid components; standard analytical techniques for macromolecules
• Demonstrated understanding of the current regulatory requirements for drug product development
• Expertise in nanoparticle based oligonucleotide delivery systems
• Experience getting drug products into the clinic
• Visionary for building new nanoparticles technology for various target tissues
• Ability to build and lead a team of research specialists and scientists
• Experience in LNP production, process development, and physicochemical characterization
• Ability to establish methods for high-throughput LNP formulation development
• Design and execution of experiments to understand the mechanism of LNP delivery to various tissues and cell types
• Knowledge of IP and key deliverables in nanoparticle delivery strategy
• Strong communication and collaboration skills to manage interactions across the company and with external partners
• Experience in tech transfer and coordination of contract manufacturing organizations (CMOs) for GxP material supply.

• Salary commensurate with experience
• Intellectually stimulating and fast-paced environment
• Equal opportunity employer
• Diverse environment
• Collegial work environment
• Opportunity to work with lipid nanoparticles for the next generation of genetic medicines