AnaptysBio is seeking a Director to lead antibody downstream process development and technical transfer activities supporting all stages of development through commercial manufacturing at CMOs. Additionally, this person will hands on experience in antibody purification, viral clearance strategies, technical transfer, DOE, QbD, CMC, process validation, and supporting analytical methodologies. Experience leading and managing multiple projects from early to late stage process development through commercial manufacturing with both internal and external partners is required. The candidate should have strong technical, communication and interpersonal skills, and work across diverse, cross-functional teams.
BS/MS degree in life sciences, chemical engineering, biochemical engineering or related field and
10 years of relevant industry experience
15 years of experience large- scale process equipment design, scale-up implementation & validation experience.
Expert in downstream purification operations such as centrifugation, filtration, UF/DF, chromatography, viral inactivation and viral filtration from pilot to Phase 3/commercial scale
Ability to apply analytical methods used to support biologics purification process development is needed
Experience with statistical design of experience (DoE) and Quality by Design (QbD) is preferred
Experience with technical transfer to pilot plant or cGMP manufacturing for clinical stage and commercial products, and PAI is preferred
Direct experience in authoring & reviewing CMC sections for IND's & BLA's required, experience interacting with regulators concerning product quality attributes, setting process and product specifications also required