This position requires a strong industry background with at least 10-15 years of experience. The ideal candidate is proficient in operating a pharmaceutical pilot plant or a commercial facility in the downstream processing field. Professional knowledge and specific experience in chromatographic plate modeling. Manual experience with various sizes of columns. Candidates need to understand the impact of DSP parameters on recovery rate and yield. The person needs to have a good understanding of DQ, FAT, SAT, IQ, OQ, and PQ (debugging and qualification). Candidates must have experience working with the FDA and have a solid understanding of the quality system in areas such as deviation, investigation, CAPA, and change control. Individuals should have experience in CIP, SIP, clean rooms, and water systems (pure water, pure steam, and WFI). Individuals should have strong communication skills, teamwork skills, and leadership skills.

The candidate will lead a team of over 50 people in the field of clinical commercial downstream processing (DSP). The personnel will analyze historical data to support process amplification between clinical and commercial production facilities. This will include troubleshooting observed process differences, as well as deriving and improving current scaling techniques and tools. This position will also be responsible for process characterization, hands-on purification on a pilot commercial scale using the GEAKTA system, as well as related experimental planning, coordination, and report writing. Candidates need to have experience leading a team, a goal oriented mindset, and a capable attitude. Candidates will work with upstream processing (UPS), quality assurance, quality control, engineering, supply chain, PD, planning, regulation, logistics, project management and procurement.