Associate Director, Drug Substance Process Development

About Sail:

Sail Biomedicines is harnessing evolutionary and artificial intelligence to revolutionize programmable medicines. Sail’s platform combines first-in-class programmable RNA technology (Endless RNA^TM or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.

The Role:

Sail Biomedicines is seeking a highly motivated and innovative Associate Director, Drug Substance Process Development to be the subject matter expert and leader of RNA manufacturing processes, including upstream and downstream activities. As a leader within the Technical Operations department, you will oversee and actively contribute to the development of drug substances (RNA) processes for scale-up and clinical manufacturing, as well as supporting internal efforts for preclinical supply and overall platform process understanding. You will closely collaborate across the entire organization, including process development, platform, applications, strategy, and supply chain functions to advance our programmable medicines.

Responsibilities

• Lead and mentor a team of scientists developing novel processes for eRNA manufacture to enable process efficacy, scalability and delivery of high-quality drug substance.
• Interface with the Platform, drug product process development, internal preclinical & external clinical manufacturing, and analytical development teams to enable harmonization of processes.
• Establish scalability of the process and a path to establishing a platform process across all programs. 
• Define drug substance related process design space, including product and intermediate stability.
• Develop IVT and purification approaches to produce drug substance of appropriate quality attributes.
• Design, lead and drive experiments for screening, optimization and scale-up of all RNA based methods, leveraging DoE, including IVT, chromatography and filtration separations.
• Contribute to regulatory engagements and filings for clinical stage programs.
• Oversee the transfer of processes to internal production team and external CDMOs.
• Apply and develop state-of-the-art technologies and solutions using novel processes and translatable industries.
• Develop, refine and deploy unit operations for enzymatic reactions; characterize enzymatic reactions using first principles.
• Co-develop characterization methods with analytical team to assess quality of the material
• Troubleshoot lab workflows, maintain equipment and support IND enabling manufacturing batches.

Qualifications:

• PhD 6+, MS 10+, BS 12+  years of industry experience or equivalent experience in bioengineering, chemical engineering, biology, virology, biochemistry or related field
• 8 years leading/mentoring scientific staff, within the process development space.
• Expertise in biologics Purification development such as nucleic acids protein, and/or AAV 
• Experience leading cross-functional and CMC sub-teams through direct and indirect reporting structures
• Expertise in novel therapeutics-focused platforms and modality technologies preferred.
• Experience delivering on strategic timelines and executing successfully on corporate goals
• Expertise in nucleic acid synthesis, purification, enzymes, manufacturing, analytics and/or formulation
• Hands on experience using separation instruments like HPLC, AKTA and TFF 
• Experience and/or understanding in nucleic acid chemistry, enzymatic reactions, PCR, plasmid processing and standard analytical techniques
• Experience with custom affinity resins and knowledge of continuous processing applications.