Thermo Fisher Scientific

Development and Scale-Up Engineer: HPLC Media Production

Posted on: 30 Jan 2021

Sunnyvale, CA

Job Description

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 focus on 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.

Work with the development lead engineering and operations to scale up for the manufacturing of chromatographic media from the 100s g scale to 1-10kg scale for new products and current products
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
Evaluate new equipment and hardware to make recommendations for modifications to associated equipment and components used for chromatography media production
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

How will you get here?
Education
B.S. in Chemistry, Materials Science and Engineering, Chemical Engineering, or related discipline; M.S. degree is a plus

Experience
Chemistry or chemical engineering laboratory experience with a 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 100s milliliter scale to the kilograms and 1-10s 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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific

Waltham, MA

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

To serve science, Thermo Fisher Scientific needs to stay ahead of it. To be the world leader in serving science, we need to anticipate (pre-empt) customer needs. We need to constantly think about advancing science, so customers have the freedom to be bolder and more innovative – we are committed to pushing science and technology a step beyond where it is today.