Director, Purification Process Science

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, Purification to join the Technical Operations 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 building robust, scalable purification processes with a QbD approach.

The candidate will have the opportunity to lead a 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 Substance Group with focus on mRNA and synthetic oligonucleotide purification process development and scale-up; with the potential to also work on AAV development.
• Drive technology innovation (for example, continuous manufacturing) to improve product quality, process robustness, productivity, and efficiency of downstream purification processes for mRNA and sgRNA for gene editing modalities
• Lead the downstream team and process development projects, and be accountable for delivering robust purification processes for novel mRNA encoding Scribe’s gene editing enzymes and synthetic oligo guide RNAs
• Work with team scientist to design and perform process development studies on mRNA and sgRNA purification at bench scale and/or pilot scale, using engineering principles
• 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 and Drug Product 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.

Required Skills and Background:

• 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 Purification process development.
• Demonstrated understanding of the current regulatory landscape in QbD and process development, especially in gene therapy or gene editing drug substance areas.
• Technical understanding and experience in biopharmaceutical process manufacturing operations including industry cGMP environment and tech transfer to CMO/CRO.
• Experience 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

Preferred Skills and Background:

• Familiarity with CRISPR technologies and therapeutic approaches

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.