Director, Drug Product Development

Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design™ platform for CRISPR-based genetic medicine.

We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for a Director, Drug Product Development to join the Technical Operation’s leadership  team and advance Scribe’s platform. The candidate should have a passion for working collaboratively to enable building the necessary delivery platform to meet the new frontier of CRISPR-based therapeutics. Additionally, the candidate would bring expertise in nanoparticle based oligonucleotide delivery systems, experience getting drug products into the clinic, and be a visionary for building new nanoparticles technology for various target tissues.

The candidate will have the opportunity to build their team  in a rapidly growing biotechnology start-up and the ability to bring the next generation gene editing drug products to the patients. 

Key Responsibilities:

• 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.
• Establish methods to support high-throughput LNP formulation development to enable screening new CRISPR technologies and build a robust,  scalable process to clinical production.
• Manage a core function of the team to produce, physiochemically characterize, and optimize LNP production.
• 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
• Design and execution of experiments that elucidate the mechanism of LNP delivery to various tissues and cell types
• Guide Scribe’s nanoparticle delivery strategy, with a particular emphasis on IP and key deliverables
• Manage 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)
• Lead tech transfer, and coordination of contract manufacturing organizations (CMOs) for GxP material supply.

• PhD with 8+ years of relevant industrial experience with a degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Biochemistry, or related field is 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 landscape in therapeutic discovery, and process development, especially in gene therapy, gene editing, mRNA, siRNA, or antisense oligos.
• Technical understanding and experience in biopharmaceutical process manufacturing operations including industry cGMP environment and tech transfer to CMO/CRO.
• Experience with formulation and process development techniques and statistical design of experiments (DoE) strongly preferred.
• Proven track record of completing deliverables within specified timelines.
• Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner
• The candidate should be collaborative, communicative, and passionate about working with lipid nanoparticles for the next generation of genetic medicines.
• Knowledge of current regulatory guidance and experience in managing and authoring  IND/IMPD and BLA filings

• Familiarity with CRISPR technologies and therapeutic approaches
• Some familiarity with oligonucleotide and lipid interactions that might effect delivery

Salary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you! Visit us at www.scribetx.com.  

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.