Downstream Process

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:
  • 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
• KPG123