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Downstream Process Specialist Jobs (NOW HIRING)

Downstream Process Analytics Specialist Industry: Biopharmaceutical CDMO / Biologics Manufacturing Location: Irvine, CA (Onsite) Employment Type: Full-Time Schedule: Mondayâ€"Friday | Standard ...

NY · On-site

$80 - $100/hr

JR-0092381(Global) Business Process Specialist (m/f/d) Central Industrial Engineering - ITS EMEA ... Align with the global DtB IE Template Team and coordinate upstream/downstream processes (StProd, QM ...

Sell Thermo Fisher's Downstream Workflow products to biotech and biopharma accounts for process development and manufacturing. This highly valued individual contributor will model and act in ...

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How much do downstream process specialist jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for downstream process specialist in the United States is $35.82, according to ZipRecruiter salary data. Most workers in this role earn between $24.52 and $41.83 per hour, depending on experience, location, and employer.

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Infographic showing various Downstream Process Specialist job openings in the United States as of June 2026, with employment types broken down into 1% Locum Tenens, 97% Full Time, and 2% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $74,515 per year, or $35.8 per hour.

Downstream Process

Tustin, CA • On-site

Kinetic Personnel Group
Recruiting and Staffing Services • 501 - 1,000 employees

Full-time

This job post has expired today. Applications are no longer accepted.


Job description

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.
QualificationsEducation
  • Bachelor's degree in:
    • Chemical Engineering
    • Biochemistry
    • Biology
    • Biotechnology
    • Biomedical Engineering
    • Biochemical Engineering
  • KPG123