MST Senior Scientist

Socket.dev; Oklahoma; On-site; USD 180,000 - 240,000; Full time

Job summary

Socket.dev is seeking an independent technical leader to drive technology transfer, process scale-up, and manufacturing support for biopharmaceutical programs. You will lead cross-functional activities from process transfer through GMP manufacturing, ensuring regulatory compliance and technical rigor.

You will mentor junior engineers, manage investigations, and collaborate across Process Development, Manufacturing, QC, QA, Facilities and Supply Chain to deliver robust, compliant processes and

Qualifications

• BS/MS/PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, Biology or Microbiology.
• Minimum 10 years of biopharmaceutical industry experience with 5 years in MSAT.
• Demonstrated MSAT, technology transfer, scale-up and manufacturing support experience.
• Independent lead of technical investigations with sound scientific decisions.
• Excellent technical writing for protocols, reports and investigations.
• Strong project management and organizational skills.

Responsibilities

• Lead technology transfer from clients and internal Process Development into GMP manufacturing.
• Author comprehensive Technology Transfer Protocols with detailed manufacturing batch records.
• Develop process descriptions, manufacturing instructions, engineering calculations, and scale-up strategies.
• Perform scale-up calculations for upstream and downstream operations and justify scale-up parameters.
• Identify technical risks in scale-up and develop mitigation strategies.
• Generate, review, and approve Bills of Materials (BOMs) for client approval and 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 identify root causes and implement CAPAs.
• Support change controls, process validation, characterization, and comparability studies.
• Serve as technical interface with Process Development, Manufacturing, QC, QA, Facilities, Supply Chain, PM, and clients.
• Mentor junior engineers/scientists and provide technical leadership.

Skills

MSAT experience

Technology transfer

Process scale-up

GMP manufacturing

Statistical analysis

Education

BS/MS/PhD in Chemical Engineering

Biochemical Engineering

Biochemistry or Microbiology

Job description

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.