A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
As a member of the Groton Engineering Technologies group in Chemical R&D, will provide engineering process development, technology transfer, and regulatory filing support for the development of robust, safe, and economical manufacturing processes for small molecule drug substance intermediates and APIs to internal Pfizer and external API manufacturing facilities. As a technology leader, will identify, develop, and apply existing and new chemical development technology to advance process understanding.
- On API project teams, applies chemical engineering principles (reaction kinetics, thermodynamics, heat and mass transfer, and mixing effects) to evaluate and develop scalable and robust processes for the manufacture of active drug substances. - Develops and applies new and existing process technologies to enable development and transfer of safe and scalable processes to API manufacturing facilities, - Leverages engineering modeling to efficiently probe the design space in the laboratory and rapidly develop optimal manufacturing processes. - Working in a modern automated laboratory, performs laboratory experiments to develop process understanding using a One Factor at a Time (OFAT) and/or a Design of Experiments (DoE) methodology as appropriate. Performs experiments to understand reaction mechanisms and kinetics, stability, solvent exchange, etc. - Supports technology transfer of drug substance processes to internal Pfizer API manufacturing facilities and external suppliers. Serves as a key point of accountability for new product site registration and validation activities. May spend significant time at the PGS launch site supporting process validation and Pre-Approval Inspection (PAI) activities. Applies chemical engineering skills and specific process knowledge to understand and resolve scale-up issues during transfer. - Contributes to the preparation of the CMC section of the NDA. Participates in data verification, PAI preparedness, and post submission query response, - Champions the development of novel laboratory development instrumentation and software modeling tools to improve process understanding. Leads the development and implementation of new and existing workflows and methodologies. - Remains current with the process engineering and chemistry literature. Collaborates and prepared internal research reports and technical presentation. May collaborate and author external publications and present research at external conferences.