Director, Antibody Conjugation Process Development

Role Summary

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

Responsibilities

• Lead process development, optimization, scale-up, and process characterization of antibody conjugates for platform delivery of oligonucleotide APIs.
• Contribute to the development of long-term strategy for platform delivery programs and provide recommendations to the leadership team.
• Oversee downstream process development and contract manufacturing of antibody oligonucleotide 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 at least 10 years of process research and development experience in the manufacture of antibody drug conjugates.
• Demonstrated proficiency in the design, development, and scale-up of processes for manufacture of antibody-drug conjugates (ADCs).
• Extensive experience in downstream process development, conjugation, purification, and characterization of ADCs including mAbs.
• Hands-on experience with process development and analytical methods for process and product characterization.
• Demonstrated experience and understanding of analytical methods and techniques as well as upstream process development is a plus.
• Experience in process transfer and management of contract manufacturing at CDMOs.
• Excellent organizational and communication skills.
• Demonstrated strong operational execution and problem-solving skills.
• Desire to work in a fast-paced, deadline-driven environment.