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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

· 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.