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.