Senior Scientist - Chemical Engineer for API Manufacturing Process Development

Why Patients Need You 

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. 

What You will Achieve  

We are seeking a highly motivated chemical engineer for the role of Senior Scientist-Chemical Engineer for API Process Development within Chemical Research and Development (CRD) in Groton, CT. You will join a diverse team responsible for developing Active Pharmaceutical Ingredients (API) processes for use at manufacturing plants across Pfizer’s network. Chemical engineering principles contribute to the successful development, optimization and scale up of API manufacturing processes. You will design and perform engineering-related laboratory experiments, in combination with process simulation and statistics. Strong communication, high technical aptitude, and creativity to foster original ideas are required for success in this position.  

CRD, as part of Pfizer R&D in Pharmaceutical Sciences, is responsible for the development of process technology to manufacture active pharmaceutical ingredients (API). CRD scientists engage in all facets of development from small-scale synthesis in support of medicinal chemistry programs, to the development of the commercial synthetic route. In collaboration with chemists and analysts, you will lead the engineering activities during process development, process scale up, and technology transfer to our clinical and commercial manufacturing sites and external facilities. Given the dynamic team environment and fast-paced project timelines, strong interpersonal and communication skills are essential. This laboratory-based position offers the opportunity for cross-training and innovation of new technologies and processes.  

How You Will Achieve It 

• Apply chemical engineering principles to design and perform experiments using modern laboratory instrumentation to develop robust unit operations and increase process understanding.  

• Assess scalability and robustness for API processes with understanding of large-scale manufacturing equipment, capabilities, and operations. 

• Select, develop, and apply new process technologies (batch, semi-batch, and continuous flow) to facilitate process design to achieve project goals. 

• Support technology transfer of processes to internal clinical and commercial API manufacturing facilities and external suppliers. May spend time at the commercial launch site supporting process validation activities.  

• Apply process simulation tools and statistical packages to understand the kinetic and thermodynamic factors impacting various unit operations, such as reaction, extraction, distillation, crystallization, filtration, and drying. 

• Prepare internal research reports and technical presentations summarizing API process development activities to capture process knowledge and transfer process understanding to Pfizer’s commercial manufacturing.  

• Champion the development of novel laboratory instrumentation and computational tools to increase knowledge capture and process understanding. Support the development and implementation of new and existing workflows and methodologies. 

• Remain current with the process engineering and chemistry literature. May collaborate and author external publications and present research at external conferences. 

• Contributes to the preparation of the Chemistry and Manufacturing Controls (CMC) section of the New Drug Application (NDA). Participate in data verification, PAI preparedness, and post submission query response. 

Qualifications 

Must-Have 

• MS in Chemical Engineering with 5+ years of experience or PhD in Chemical Engineering with 0-3 years of relevant experience 

• Excellent knowledge of chemistry and chemical engineering principles and sound understanding of applied reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, and process modeling  

• Outstanding laboratory skills, attention to detail, and ability to solve technical problems 

• Exceptional interpersonal, multi-disciplinary team collaboration, and communication skills 

Nice-to-Have 

• Working knowledge of reaction modeling, property prediction, and process simulation tools including: Aspen, gPROMS, DynoChem, VisiMix, and COSMOtherm 

• A good foundational understanding of organic chemistry 

• Demonstrated laboratory and computational experience in reaction engineering topics  

• Working knowledge of crystallization development 

• Working knowledge of Design of Experiment (DOE) studies and statistical analysis 

• Working knowledge of analytical techniques such as HPLC/UPLC, MS, PXRD, DSC, TGA, and NMR 

• Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, Raman, FBRM, UV/Vis 

• Computational fluid dynamics (CFD) expertise in M-Star or Fluent 

• Programing experience, including Python and/or Matlab 

• Applied data science methods, such as machine learning and AI  

• Experience in automating laboratory equipment and processes including use of LabView