Downstream Process
Job in
Tustin, Orange County, California, 92681, USA
Listed on 2026-09-03
Listing for:
Kinetic Personnel Group
Full Time
position Listed on 2026-09-03
Job specializations:
-
Manufacturing / Production
Validation Engineer, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Downstream Process Analytics Specialist Industry: Biopharmaceutical CDMO / Biologics Manufacturing
Location:
Irvine, CA (Onsite)
Employment Type:
Full-Time
Schedule:
MondayâFriday | Standard Business Hours (Flexibility for manufacturing support as needed) Position Summary Our client, a growing biopharmaceutical CDMO, is seeking a Downstream Process Analytics Specialist to support commercial and clinical manufacturing operations. This role will partner with Manufacturing, Process Development, Quality, and MSAT teams to analyze downstream purification process data, identify trends, optimize manufacturing performance, and support continuous process improvement initiatives.
The ideal candidate will have experience working in a GMP biologics manufacturing environment with downstream purification processes and strong analytical and statistical skills. Essential Responsibilities Analyze manufacturing process data from downstream purification operations, including:
Chromatography Tangential Flow Filtration (TFF) Viral Filtration Ultrafiltration/Diafiltration (UF/DF) Monitor critical process parameters (CPPs) and critical quality attributes (CQAs). Perform trend analysis using statistical tools to identify process variability and improvement opportunities. Develop dashboards and reports to communicate manufacturing performance metrics. Support investigations involving deviations, CAPAs, and out-of-trend manufacturing results. Collaborate with Manufacturing, MSAT, Process Development, Validation, and Quality teams to improve process robustness.
Evaluate process yield, recovery, cycle time, and resin performance. Generate technical reports and present findings to cross-functional teams. Assist with technology transfers and process characterization studies. Support Continued Process Verification (CPV) and Process Performance Qualification (PPQ) activities. Ensure all documentation complies with GMP, FDA, and ICH guidelines. Qualifications Education Bachelor's degree in:
Chemical Engineering Biochemistry Biology Biotechnology Biomedical Engineering Biochemical Engineering KPG
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