Director, Antibody Conjugation Process Development

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. 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.