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Senior Principal Development Engineer


Groton, CT
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Job Details

Job Title Senior Principal Development Engineer

JobID 1040783-1852

Location: Groton, CT

Description *About Pfizer*

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.

*Role Description*

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.


Required Education/ExperienceBS/MS Chemical Engineering with a minimum of 9 years relevant chemical or pharmaceutical process development and technology transfer experience or PhD in Chemical Engineering with a minimum of 4 years of experience. Experience in working in a fine chemical or API manufacturing facility with a good knowledge of batch unit operations is strongly preferred.Required Technical SkillsA good understanding of organic chemistry and chemical engineering principles. Familiarity with in-situ analytical tools (e.g FTIR, FBRM, and UV/Vis) and common analytical chemistry instrumentation including UPLC, HPLC, and MS. Preferred Technical SkillsA working knowledge of organic and/or physical organic chemistry and chemical engineering principles. A working knowledge of reaction modeling, material property prediction, and simulation using computational tools including: DynoChem, Visimix, Aspen, Fluent, and Cosmotherm. Working knowledge of application of in-situ analysis tools to process understanding including: FTIR, FBRM, and UV/Vis. Working knowledge of UPLC, MS, and NMR spectroscopy.PHYSICAL/MENTAL REQUIREMENTS Ability to work in a laboratory environment performing experiments in a laboratory fume hood. Ability to perform complex data analysis.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Will be required to occasionally travel internationally (0-10%) to support clinical manufacturing activities as well as technology transfer to commercial manufacturing.

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Senior Principal Development Engineer*
*Groton, Connecticut*

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