Downstream Manufacturing Technical Specialist

🚀 Downstream Manufacturing Technical Specialist

📍 Tustin, CA | On-site

🗓 Monday–Friday | 8:00 AM – 5:00 PM

🌱 Support the Manufacturing of Life-Saving Biopharmaceuticals

🎓 Ideal opportunity for downstream bioprocessing professionals with technical manufacturing expertise and commercial GMP experience.

Are you passionate about downstream manufacturing, process transfer, and technical operations? We're looking for a Downstream Manufacturing Technical Specialist to support manufacturing readiness, process execution, equipment oversight, and cross-functional collaboration within a commercial biologics manufacturing environment.

🔬 What You'll Do

✔ Support the successful transfer and execution of downstream manufacturing processes

✔ Serve as a key technical liaison between Manufacturing, MSAT, QA, Facilities, and other cross-functional teams

✔ Support review and approval of batch production records, manufacturing documentation, and technical reports

✔ Collaborate on process improvements to enhance performance, efficiency, robustness, compliance, and safety

✔ Manage downstream equipment readiness, utilization, calibration schedules, and manufacturing support needs

✔ Lead technical and on-the-job training activities for downstream manufacturing personnel

✔ Support technical investigations, CAPAs, and manufacturing issue resolution activities

✔ Communicate manufacturing process status and provide technical support for production operations

✅ What We're Looking For

🎓 B.S. or M.S. in a scientific or engineering discipline (Chemical Engineering, Biomedical Engineering, or related field)

🧪 4+ years of downstream manufacturing experience with a B.S. degree or 2+ years with an M.S. degree

🧪 Strong technical experience in commercial cGMP manufacturing environments

🧪 Technical expertise in downstream processing operations and equipment

🎯 Experience supporting purification and bioprocessing activities including chromatography, filtration, viral clearance, and bulk drug substance manufacturing

💰 Compensation

Hourly Rate: $25.48 - $34.00 per hour

✅ Additional compensation and benefits package available

📍 Please Note

✅ On-site in Tustin, CA

✅ Full-time position

✅ Schedule is Monday through Friday, 8:00 AM to 5:00 PM

✅ Overtime, weekend, and holiday support may be required based on business needs

🚫 No relocation assistance mentioned

🚫 No visa sponsorship information provided

If this sounds like you, or someone in your network, I'd love to connect!

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