Manufacturing Technical Specialist Downstream

BioTalent; Tustin (CA); On-site; USD 90,000 - 130,000; Full time

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

Looking for a Downstream Manufacturing Technical Specialist to support the successful transfer and execution of biologics manufacturing processes while serving as a key technical partner to Manufacturing, MSAT, QA, Facilities, and other cross-functional teams.

What we're looking for:

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

What you'll be doing:

• 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

Work Authorization:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time

If you're passionate about biopharmaceutical manufacturing, employee development, and building a strong GMP culture, I'd love to connect!

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