MSAT Senior Scientist - Technology Transfer & Scale-Up

Cytovance Biologics; Oklahoma City (OK); On-site; USD 140,000 - 210,000; Full time

Job summary

Cytovance Biologics in Oklahoma City seeks an independent technical leader responsible for technology transfer, process scale-up, manufacturing support, and continuous improvement for biopharmaceutical manufacturing.

You will lead cross-functional activities from process transfer through GMP manufacturing, mentor junior staff, and drive CAPAs, deviations, and investigations to ensure regulatory compliance.

Qualifications

• BS/MS/PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, Biology, Microbiology, or related discipline.
• Minimum 10 years of biopharmaceutical industry experience with 5 years in MSAT.
• Demonstrated experience in MSAT, technology transfer, scale-up, and manufacturing support.
• Ability to independently lead technical investigations and make sound scientific decisions.
• Excellent technical writing skills for protocols, reports, and investigations.

Responsibilities

• Lead technology transfer from clients and internal Process Development into GMP manufacturing.
• Author comprehensive Technology Transfer Protocols that provide sufficient technical detail for manufacturing batch record development.
• Develop process descriptions, manufacturing instructions, engineering calculations, and scale-up strategies.
• Perform process scale-up calculations for upstream and downstream operations and select scientifically justified scale-up parameters.
• Identify technical risks associated with scale-up and develop mitigation strategies.
• Generate, review, and approve Bills of Materials (BOMs); ensure technical accuracy because BOMs are provided to clients for approval and drive project cost.
• Support batch record development and manufacturing execution.
• Provide on-floor manufacturing support during engineering, clinical, PPQ, and commercial campaigns.
• Lead deviation, OOS, and OOT investigations to scientifically determine root causes and implement effective CAPAs.
• Support change controls, process validation, process characterization, comparability studies, and continuous improvement.
• Serve as technical interface with Process Development, Manufacturing, QC, QA, Facilities, Supply Chain, Project Management, and clients.
• Mentor junior engineers/scientists and provide technical leadership.

Skills

Technical leadership

MSAT

Technology transfer

Scale-up

GMP manufacturing

Process validation

Risk management

Cross-functional collaboration

Education

BS/MS/PhD in Chemical/Biochemical/Bioengineering or related

Job description

Cytovance Biologics in Oklahoma City seeks an independent technical leader responsible for technology transfer, process scale-up, manufacturing support, and continuous improvement for biopharmaceutical manufacturing.

You will lead cross-functional activities from process transfer through GMP manufacturing, mentor junior staff, and drive CAPAs, deviations, and investigations to ensure regulatory compliance.