Downstream Manufacturing Technical Specialist

BioTalent; Tustin (CA); On-site; USD 34,000 - 47,000; Full time

Benefits offered by this job

Additional compensation and benefits

Job summary

BioTalent is seeking a Downstream Manufacturing Technical Specialist to support the transfer and execution of downstream bioprocessing in a commercial biologics plant. The role involves equipment oversight, cross-functional collaboration, and ensuring readiness for manufacturing operations in a cGMP environment.

On-site in Tustin, CA, the position requires collaboration with Manufacturing, MSAT, QA, and Facilities, with standard Monday–Friday hours and occasional overtime to meet business needs.

Qualifications

• B.S. or M.S. in a scientific or engineering discipline (Chemical Engineering, Biomedical Engineering, or related field).
• 4+ years downstream manufacturing with a B.S. or 2+ years with an M.S.
• Strong technical experience in commercial cGMP manufacturing.
• Technical expertise in downstream processing operations and equipment.
• Experience with purification and bioprocessing including chromatography, filtration, viral clearance, and BDS manufacturing.

Responsibilities

• Support transfer and execution of downstream manufacturing processes.
• Serve as liaison between Manufacturing, MSAT, QA, Facilities, and cross-functional teams.
• Review batch production records, manufacturing docs, 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.
• Communicate manufacturing process status and provide technical support for production operations.

Skills

Downstream manufacturing

cGMP

Cross-functional collaboration

Chromatography

Filtration

Education

B.S./M.S. in Chemical/Biomedical Engineering or related

Job description

Downstream Manufacturing Technical Specialist

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

Hourly Rate: $25.48 - $34.00 per hour

Additional compensation and benefits package available

Please Note

• On-site in Tustin, CA
• Schedule is Monday through Friday, 8:00 AM to 5:00 PM
• Overtime, weekend, and holiday support may be required based on business needs