About this opportunity
CYTOVANCE BIOLOGICS lists this MSAT Senior Scientist opportunity in oklahoma city, Oklahoma. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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MSAT Senior Scientist
Full Time Oklahoma City, OK, US
{0} days ago Requisition ID: 1023
Position Summary
This role serves as an independent technical leader responsible for technology transfer, process scale-up, manufacturing support, process troubleshooting, and continuous improvement for commercial and clinical biopharmaceutical manufacturing. The individual will lead cross-functional activities from process transfer through GMP manufacturing while ensuring technical rigor, regulatory compliance, and successful execution.
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.
Technical Expertise
Strong knowledge of upstream cell culture and/or microbial fermentation and downstream purification; downstream expertise preferred.
Deep understanding of process scale-up principles including mixing, oxygen transfer, chromatography, filtration (terminal, viral, depth), UF/DF, and centrifugation.
Experience supporting GMP manufacturing and MSAT workflows.
Knowledge of process validation, process characterization, statistical analysis, and risk management.
Experience preparing technical reports, protocols, investigations, and client-facing documentation.
Experience with Some of Root Cause Analysis & Investigation Tools
Fishbone (Ishikawa/5M or 6M) Diagram
Fault Tree Analysis (FTA)
Failure Modes and Effects Analysis (FMEA)
Control Charts (SPC)
Trend Analysis
Process Capability Analysis
Hypothesis Testing (t-test, ANOVA, chi-square as appropriate)
Regression and Correlation Analysis
Qualifications
BS, MS, or 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.
Strong project management and organizational skills.
Excellent communication and presentation skills.
Build trust across cross-functional teams.
Professional, collaborative, and customer-focused.
Able to influence without direct authority.
Comfortable interacting with clients and senior management.
Strong analytical thinking and sound technical judgment.
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Worksite address
oklahoma city, OK, 73116, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.