Director, Process Sciences

Role Summary

The Director, Process Sciences is responsible for process development, optimization, scale-up and process characterization of drug candidates for platform delivery of oligonucleotide APIs, working with cross-functional teams and contract manufacturers on process development, transfer, and oversight of manufacturing processes. This position is onsite at Kendall Square, Cambridge, MA.

Responsibilities

• Lead process development, optimization, scale-up, and process characterization of antibody and peptide conjugates for platform delivery of oligonucleotide APIs.
• Oversee API contract manufacturing of antibody and peptide conjugates.
• Author and review technical documentation supporting API manufacture and process characterization activities.
• Prepare the Quality section for regulatory filings and interact with regulatory authorities.
• Contribute to strategic technical discussions and present progress at internal and external meetings.
• Represent Process Development on cross-functional teams including internal program teams and externally with contract manufacturing and/or corporate partners.
• Integrate Process Development activities with other CMC functions in Drug Substance Development & Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs.
• Periodic travel to manufacturing and other partner sites is required.

Qualifications

• Ph.D. in chemistry, chemical engineering, or biochemical engineering with a minimum of 10 years of process R&D experience in the manufacture of antibody and peptide conjugates.
• Proficiency in design, development, and scale-up of processes for manufacture of antibody-drug conjugates (ADCs).
• Experience and in-depth understanding of process and analytical methods and techniques.
• Hands-on experience in process development and analytical methods for process and product characterization.
• Experience in process transfer and management of contract manufacturing.
• Excellent organizational and communication skills.
• Strong operational execution and problem-solving skills.
• Desire to work in a fast-paced, deadline-driven environment.