Job Title: Downstream Process Analytics Specialist Industry: Biopharmaceutical CDMO / Biologics Manufacturing Location: Irvine, CA (Onsite) Employment Type: Full-Time Schedule: Monday–Friday | 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:ChromatographyTangential Flow Filtration (TFF)Viral FiltrationUltrafiltration/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.
QualificationsEducation
Bachelor's degree in:Chemical EngineeringBiochemistryBiologyBiotechnologyBiomedical EngineeringBiochemical EngineeringKPG123
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This position is listed as full time and onsite.