Korro Bio
Director, Process Development
Korro Bio is seeking a Director of Process Development to join the growing CMC (Chemistry, Manufacturing, and Controls) team. You will play a critical role in developing and optimizing manufacturing processes for our oligonucleotide-based Therapeutics. This role requires a deep understanding of process development, scale-up, and technology transfer for drug substance as well as cross-functional collaboration with internal 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 manufacturing processes for synthetic oligonucleotide drug substance. Oversee process characterization, scale-up activities, and tech transfer to external manufacturing partners. Develop and implement CMC strategies for process development to support early-stage clinical programs as well as process characterization/validation for late-stage programs to commercialization. Collaborate cross-functionally with R&D, quality assurance, regulatory affairs, and external CMOs (Contract Manufacturing Organizations) to align 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 Organic Chemistry, Chemical Engineering, or a related field; or equivalent combination of education and experience. 5+ years hands-on experience in oligonucleotide synthesis and manufacturing process characterization (DoE studies) and scale up activities. Proven track record in leading process development from preclinical and clinical phases to commercialization, including technology transfer to manufacturing. Experience working with CDMOs 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. Ability to work onsite 3 days per week. 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.
Korro Bio is seeking a Director of Process Development to join the growing CMC (Chemistry, Manufacturing, and Controls) team. You will play a critical role in developing and optimizing manufacturing processes for our oligonucleotide-based Therapeutics. This role requires a deep understanding of process development, scale-up, and technology transfer for drug substance as well as cross-functional collaboration with internal 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 manufacturing processes for synthetic oligonucleotide drug substance. Oversee process characterization, scale-up activities, and tech transfer to external manufacturing partners. Develop and implement CMC strategies for process development to support early-stage clinical programs as well as process characterization/validation for late-stage programs to commercialization. Collaborate cross-functionally with R&D, quality assurance, regulatory affairs, and external CMOs (Contract Manufacturing Organizations) to align 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 Organic Chemistry, Chemical Engineering, or a related field; or equivalent combination of education and experience. 5+ years hands-on experience in oligonucleotide synthesis and manufacturing process characterization (DoE studies) and scale up activities. Proven track record in leading process development from preclinical and clinical phases to commercialization, including technology transfer to manufacturing. Experience working with CDMOs 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. Ability to work onsite 3 days per week. 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.