职位信息

The candidate will
lead a group of 5-10 people in the clinical/commercial downstream processing
(DSP) area.  The individual will perform
analysis of historical data to support process scale-up across facilities in
clinical & commercial manufacturing. This will include troubleshooting
observed process differences as well as deriving and improving current scaling
techniques and tools. The position will also entail process characterization,
hands-on purification using GE AKTA system at pilot/commercial scale along with
the associated experimental planning, coordination, and report writing.  The candidate need to have experience in
leading a team, a goal oriented mindset, and a can-do attitude.  The candidate will work with Upstream
Processing (UPS), QA, QC, Engineering, Supply Chain, PD, Planning, Regulatory,
Logistics, Project Management and Strategic Sourcing/Procurement.

• The position requires a strong industry background with at least 7-9 years of experience. The ideal candidate will have proficiency in operating a drug substance pilot plant and/or a commercial facility in the downstream processing arena. Expertise and specific experiences modeling chromatography skids. Hands-on experience with various size columns. The candidate needs to understand the effects of DSP parameters on recovery and yield. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).  The candidate must have experience in dealing with FDA, EMA and CFDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. The individual should have experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI).
• BS, MS or PhD in Chemical Engineering, Biomedical Engineering, Bioscience, or Biotechnology.
• Experience required: BS, 7+ years, MS, 5+ years, PhD, 3+ years in biopharmaceutical manufacturing with extensive experience in downstream processing/purification.
• Other: The candidate must have the following attributes: Can do attitude, good organizational skill, attention to details, strong communication skill, team-oriented, leadership skill and work well with people.