Principal Scientist, Purification Process Development

Position Overview

We are seeking an experienced and motivated Principal Purification Process Development Scientist to support our growing ADC pipeline. This role will be responsible for the optimization of purification processes for antibody intermediates (mAbs).

Qualifications

• A Bachelor’s, Master’s, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
• A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Masters, or 10 years with a Bachelors, with a primary focus on purification process development, or equivalent experience.
• Prior experience with tech transfer, external CDMO engagement, and internal coordination with relevant functions.
• Prior knowledge of/experience working with GMP manufacturers and processes, including familiarity with regulatory submissions.
• Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc).
• Familiar with laboratory operations and needs for establishing a highly functioning development lab.
• Demonstrated success in developing and optimizing purification processes for monoclonal antibodies and recombinant proteins.
• Experience in regulatory submissions, responding to information requests, and interfacing with health authorities.

Knowledge and Skills

• A strong understanding of the common purification, analytical, and characterization approaches used for mAbs, with a solid foundation in overcoming some of the challenges encountered in these workflows.
• Must be a purification subject matter expert including chromatography separations and filtration operations (depth, dead-end, virus and ultrafiltration/diafiltration).
• Expert user of AKTA chromatographic instruments (such as AKTA Avant, AKTA Ready or similar).
• Design, plan, schedule, organize, prioritize, execute, document and present complex experiments using Design of Experiment (DOE) when needed.
• The ability to manage multiple projects simultaneously while being able to prioritize and balance hands-on tasks with strategic responsibilities.
• Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners.
• High-throughput liquid handling systems (Tecan) experience is a plus.