Senior Advisor, Drug Substance Process Development

Responsibilities

• Lead process development activities for circular RNA manufacturing supporting pre-clinical and clinical studies
• Identify critical process parameters and evaluate scale-up strategies
• Design and perform process development experiments using scientifically sound methodology, including design-of-experiments approaches
• Work with supply chain, quality, and CMC functions to manufacture of test article(s) and clinical trial material for preclinical studies
• Generate, interpret, and present data to cross-functional R&D teams
• Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture
• Collaborate with SMEs from external vendors to ensure oRNA process transfer and development efforts are aligned with program timelines and objectives
• Contribute to authoring regulatory documentation and provide input to regulatory interactions

Requirements

• PhD, MS, or BS degree in chemical engineering, biomedical engineering, chemistry, biology or related field with the following years of relevant industry experience: PhD 6+ years, MS 9+ years, or BS 12+ years
• Experience developing biotechnology manufacturing processes, with experience in downstream biomanufacturing technologies
• Experience working in a matrixed CMC environment (supply chain, analytical development, and formulation development)
• Experience in authoring/reviewing development sections for regulatory submissions. Strong knowledge of regulatory requirements

Qualifications

• Organized, collaborative, and able to work with a diverse group of scientists and engineers
• Demonstrated ability to work on cross-functional teams in a fast-paced, dynamic environment
• Detail oriented, self-motivated, and excited to take on new challenges!