Director, Process Sciences

Overview:

The Director, Process Sciences will be responsible for process development, optimization, scale-up and process characterization of drug candidates for platform delivery of oligonucleotide APIs. The candidate will work closely with cross-functional teams and contract manufacturing organizations on process development, process transfer, and oversight of manufacturing processes.

This position isonsite and will be located at our Kendall Square offices in 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.
• Accountable for the preparation of the Quality section for regulatory filings and interaction 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 cross-functional program teams and externally with contract manufacturing and/or corporate partners.
• Effectively 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 research and development experience in the manufacture of antibody and peptide conjugates.
• Demonstrated proficiency in the design, development, and scale-up of processes for manufacture of antibody-drug conjugates (ADCs).
• Demonstrated 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.
• Demonstrated strong operational execution and problem-solving skills.
• Desire to work in a fast-paced, deadline-driven environment.