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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
路 Lead technology transfer from clients and internal Process Development into GMP manufacturing.
路 Author comprehensive Technology Transfer Protocols that provide sufficient technical detail for manufacturing batch record development.
路 Develop process descriptions, manufacturing instructions, engineering calculations, and scale-up strategies.
路 Perform process scale-up calculations for upstream and downstream operations and select scientifically justified scale-up parameters.
路 Identify technical risks associated with scale-up and develop mitigation strategies.
路 Generate, review, and approve Bills of Materials (BOMs); ensure technical accuracy because BOMs are provided to clients for approval and drive project cost.
路 Support batch record development and manufacturing execution.
路 Provide on-floor manufacturing support during engineering, clinical, PPQ, and commercial campaigns.
路 Lead deviation, OOS, and OOT investigations to scientifically determine root causes and implement effective CAPAs.
路 Support change controls, process validation, process characterization, comparability studies, and continuous improvement.
路 Serve as technical interface with Process Development, Manufacturing, QC, QA, Facilities, Supply Chain, Project Management, and clients.
路 Mentor junior engineers/scientists and provide technical leadership.
Technical Expertise
路 Strong knowledge of upstream cell culture and/or microbial fermentation and downstream purification; downstream expertise preferred.
路 Deep understanding of process scale-up principles including mixing, oxygen transfer, chromatography, filtration (terminal, viral, depth), UF/DF, and centrifugation.
路 Experience supporting GMP manufacturing and MSAT workflows.
路 Knowledge of process validation, process characterization, statistical analysis, and risk management.
路 Experience preparing technical reports, protocols, investigations, and client-facing documentation.
Experience with Some of Root Cause Analysis & Investigation Tools
路 5 Whys
路 Fishbone (Ishikawa/5M or 6M) Diagram
路 Fault Tree Analysis (FTA)
路 Failure Modes and Effects Analysis (FMEA)
路 Pareto Analysis
路 Control Charts (SPC)
路 Trend Analysis
路 Process Capability Analysis
路 Hypothesis Testing (t-test, ANOVA, chi-square as appropriate)
路 Regression and Correlation Analysis
路 Scatter Plots
路 Histograms
Qualifications
路 BS, MS, or PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, Biology, Microbiology, or related discipline.
路 Minimum 10 years of biopharmaceutical industry experience with 5 years in MSAT
路 Demonstrated experience in MSAT, technology transfer, scale-up, and manufacturing support.
路 Ability to independently lead technical investigations and make sound scientific decisions.
路 Excellent technical writing skills for protocols, reports, and investigations.
路 Strong project management and organizational skills.
Leadership & Interpersonal Competencies
路 Excellent communication and presentation skills.
路 Build trust across cross-functional teams.
路 Professional, collaborative, and customer-focused.
路 Able to influence without direct authority.
路 Comfortable interacting with clients and senior management.
路 Strong analytical thinking and sound technical judgment.
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