Location/Division                    
St Louis, MO | BioProduction Division            
 
How will you make an impact?            
The Senior Data Scientist Automation will be a member of the Bio Collaboration Center (BCC) Team. The Senior Data Scientist is responsible for providing advanced level expertise to global automation projects including feasibility & concept studies, capital facility buildouts and equipment purchases, facility master plans, process improvement.         
                       
What will you do?                               

• Oversee the development of and design, implementation and maintenance for the real time GMP manufacturing process monitoring programs (e.g. SIMCA) for the development team.                 
• Have the expertise to identify potential improvement projects utilizing advanced analytics and process knowledge (PAT, QBD, etc). Working in commercial manufacturing facility and GxP experience is required.              
• Lead the development phase and the identification of key innovative real-time multivariate and predictive analytics platforms in support of new development platforms for use in clinical and commercial manufacturing unit operations.
• Work with subject matter experts both with in Patheon and Thermo Fisher Scientific, as well as in industry forums to collect and process data for use in creating models, utilizing a variety of automated tools (e.g. VBA, R/Python)
• Define and create models for individual process units, including cell culture and purification operations.             
• Work with local MSAT to provide training on the usage and representation of the multivariate models. Expertise in multivariate modeling methods, including PCA/PLS, OPLS, Discriminant analysis, etc.                
• Develop tools to support process monitoring, scientific process support, root cause analysis, transition analysis in support of chromatography columns, and projects to improve processing time, productivity, product quality, and a better customer experience.                

Education                    

•  BS in Chemical/Biochemical Engineering or Bio/Chemistry with 6 -8 years or  an MS with 4-6 years of applicable process automation, process analytics, technical support or process/facility design experience.                    

Experience                  

• Experience with process historian/data collection systems and data analysis/reporting applications such as SIMCA, PI Historian, PI Process Book, Excel, JMP and Statistica is a must.                       
• A sound technical knowledge of major unit operations associated with biologics manufacturing such as cell culture, recovery, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes is required. Experience with single-use bio-manufacturing technologies and automation strongly desired.                
• Design or operational experience with large-scale cell culture and protein purification for both clinical and commercial processes is preferred.                         
•  Experienced in an FDA regulated environment. Working knowledge of cGMP, OSHA, NEC and EPA regulations.           
• Experience with systems such as OSI PI, Infobatch and AlarmWorX, ESXi, Syncade, Pharmasuite installation and support.                       
•  Understanding in implementing MES functionality related to bio-manufacturing facility.                  
• Understanding of bridge between typical business / quality IT systems and manufacturing automation systems (ERP, LIMS, QMS, etc).                      
•  Understanding of P&ID instrumentation and loop tuning fundamentals.                 
•  Have specific subject matter expertise in process analytics and working knowledge of distributed control systems, PI historian, Statistica, LIMS, JMP and other multivariate process analytical tools.               

 
Knowledge, Skills, Abilities                

• Global travel expectations up to 20% within multiple sites for Thermo Fisher Scientific              

                       
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. 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.