Downstream Manufacturing Specialist: Biologics Tech Transfer

BioTalent

Tustin (CA)

On-site

USD 90,000 - 130,000

Full time

33 hours ago
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Job summary

BioTalent is seeking a Downstream Manufacturing Technical Specialist to support the successful transfer and execution of biologics manufacturing processes. You will serve as a key technical partner to Manufacturing, MSAT, QA, Facilities, and other cross-functional teams.

The role requires hands-on downstream experience, knowledge of chromatography, TFF, filtration, and viral inactivation, plus familiarity with AKTA chromatography systems and Unicorn software.

Qualifications

  • BS/MS in a scientific or engineering discipline.
  • 4+ years downstream manufacturing experience with a BS, or 2+ years with an MS.
  • Commercial cGMP biopharmaceutical manufacturing experience.
  • Experience with downstream operations such as chromatography, TFF, filtration, and viral inactivation.
  • Hands-on experience with AKTA systems and Unicorn software.
  • Strong troubleshooting and technical leadership skills.

Responsibilities

  • Support downstream process transfers and manufacturing execution.
  • Troubleshoot complex technical issues on the manufacturing floor.
  • Review batch records, SOPs, technical reports, and manufacturing documentation.
  • Support equipment readiness and process setup.
  • Lead technical training for Downstream Manufacturing Operators.
  • Support deviations, CAPAs, and process improvements.
  • Partner with MSAT, QA, Facilities, and Manufacturing to improve process performance and compliance.

Skills

Downstream manufacturing
Troubleshooting
Technical leadership
Communication

Education

BS/MS in science or engineering

Tools

AKTA chromatography
Unicorn software

Job description

BioTalent is seeking a Downstream Manufacturing Technical Specialist to support the successful transfer and execution of biologics manufacturing processes. You will serve as a key technical partner to Manufacturing, MSAT, QA, Facilities, and other cross-functional teams.

The role requires hands-on downstream experience, knowledge of chromatography, TFF, filtration, and viral inactivation, plus familiarity with AKTA chromatography systems and Unicorn software.

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