Development And Scale-Up Lead Engineer: HPLC Media Production

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific Information
Sunnyvale, CA / Chromatography and Mass Spectrometry Division

How will you make an impact?
As part of the chromatography consumables business, you will collaborate closely with multi-disciplinary teams consisting of scientists and product marketing to create next generation HPLC and UHPLC products used for the separation and analysis of chemical compounds and biomolecules. You will brainstorm creative approaches and tackle complex problems to introduce new and improved products for a wide range of customers including the clinical, pharmaceutical, and regulatory industries.

What will you do?
This role will function as an R&D leader for chemistry scale-up and process development of chromatographic media for HPLC chromatography columns. This work is critical to the development of equipment and procedures for consistent manufacturing of high quality products for our customers.

• Lead the development, optimization, and scale up processes for the manufacturing of chromatographic media from the 100’s g scale to 1-10kg scale for new products and current products critical to the business
• Perform daily hands-on work with equipment for chemical synthesis, separations and purification with a focus on scale-up and late stage process development
• Interface with R&D chemists and operations to identify and optimize key manufacturing parameters of new processes and processes identified for chromatographic media production
• Implement process controls to monitor and control in-process parameters critical to product performance
• Design manufacturing processes and testing protocols (e.g., instrumental analysis) that are manufacturing friendly, highly reproducible, easy to implement, and accurately indicate product performance
• Design, evaluate and work with suppliers on new equipment and hardware to purchase or for the modification current equipment
• Write detailed SOPs and work with operations engineers to transfer processes and train personnel within a ISO90001 Quality Management System
• Analyze and report results to management to measure development progress and product transfer success
• Partner with cross-functional teams in identifying and selecting Lean Projects/Kaizen Events that are aligned to key business priorities

How will you get here?
Education

• M.S. or higher in Chemistry, Materials Science and Engineering, Chemical Engineering, or related discipline desired
• B.S. in Chemistry, Materials Science and Engineering, Chemical Engineering, or related discipline with previous experience in process development and scale up

Experience

• Chemistry or chemical engineering laboratory experience with a strong focus in process development and scale-up
• Hands on experience with laboratory equipment and manufacturing equipment for chemical processes; previous experience with UHPLC and HPLC is a plus
• Process control optimization including the use of PID controllers
• Scale-up of chemical processes from the ~100 gram and ~100’s milliliter scale to the kilograms and 1-10’s of liters scale
• Previous experience with Design of Experiments (DOE) including the use of statistical software (e.g., JMP, Minitab, etc.) to design experiments and analyze results a plus
• Design and development of products and processes with associated workflows including BOMs, process validation, product transfer, procedure writing, Quality Management Systems, etc.
• Previous experience in an R&D or manufacturing environment with a focus on consumables a plus
• Previous experience with polymer synthesis, latex synthesis, silica chemistry preferred

Knowledge, Skills, Abilities

• Knowledge of chemical processes including kinetics and catalysis; heat and mass transfer; separation and purification techniques, filtration, distillation, crystallization; process control; etc.
• Instrumental analysis techniques including elemental analysis, GC-MS, liquid chromatography, dynamic light scattering, etc.
• Statistical analysis and data correlation using software such as Excel, JMP, or similar
• Previous ISO9001 Quality Management System regulatory standards or similar a plus
• Strong presentation skills

This position has not been approved for relocation assistance.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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