Associate Director/Director, Process Development

Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro's lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts. We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health. Position Summary: Korro Bio is seeking an Associate Director/director of Process Development to joining the growing CMC (Chemistry, Manufacturing, and Controls) team. You will play a critical role in developing and optimizing manufacturing processes for our RNA-based therapies. This role requires a deep understanding of solid phase process development, scale-up, and technology transfer for DS and, ideally, DP, as well as cross-functional collaboration with research, quality, and external partners. You will lead a team of scientists and engineers to ensure the scalability, efficiency, and regulatory compliance of our therapeutic development. Key Responsibilities: Lead the development and optimization of upstream and downstream manufacturing processes for RNA-based therapies. Oversee process characterization, scale-up activities, and tech transfer to internal or external manufacturing partners. Develop and implement strategies for process development to support early-stage clinical programs and eventual commercialization. Collaborate cross-functionally with R&D, quality assurance, regulatory affairs, and external CMOs (Contract Manufacturing Organizations) to align process development goals with clinical and regulatory requirements. Ensure processes comply with relevant regulatory requirements (e.g., FDA, EMA) and cGMP standards. Contribute to CMC strategy, including risk assessment, contingency planning, and troubleshooting during process scale-up or tech transfer. Lead, mentor, and develop a high-performing team of process development scientists and engineers. Manage project timelines, budgets, and resources to meet corporate milestones. Author and review key regulatory documents (IND, IMPD, NDA, etc.) in partnership with the regulatory team. Qualifications: PhD in Chemical Engineering, Biochemistry, Biotechnology, or a related field ; or equivalent combination of education and experience. 6+ years hands-on experience in oligonucleotide manufacturing and process characterizations (DoE studies) and scale up activities. Proven track record in leading process development from preclinical to clinical phases, including technology transfer to manufacturing. Experience in DP manufacturing process development and understanding the DP regulatory requirements is good to have. Experience working with CMOs and managing external collaborations. Knowledge of current Good Manufacturing Practices (cGMP) and regulatory guidelines (FDA, EMA) for biologics. Strong leadership skills with demonstrated ability to manage and mentor teams. Excellent problem-solving, communication, and organizational skills. Ability to thrive in a fast-paced, dynamic environment with changing priorities. Benefits: Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.

Created: 2024-11-05