MST Senior Scientist

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.

Essential 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.

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

• 5 Whys
• Fishbone (Ishikawa/5M or 6M) Diagram
• Fault Tree Analysis (FTA)
• Failure Modes and Effects Analysis (FMEA)
• Pareto Analysis
• Control Charts (SPC)
• Trend Analysis
• Process Capability Analysis
• Hypothesis Testing (t-test, ANOVA, chi-square as appropriate)
• Regression and Correlation Analysis
• Scatter Plots
• Histograms

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.

Leadership & Interpersonal Competencies

• 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.