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Senior Principal Scientist, Process Development

Pfizer


Location:
Groton, CT
Date:
12/07/2017
2017-12-072018-01-07
Pfizer
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Job Details

**ROLE SUMMARY**



We are seeking an experience chemical engineer to join the Chemical Research and Development (CRD) team in Groton. The successful candidate will have a demonstrated track record of combining in-silico process development with data rich experimentation to efficiently develop robust, safe and economical processes for small molecule drug substance intermediates and API's. The candidate will also have experience translating those processes to the pilot plant and commercial scale.







CRD, as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the development of process technology for the production of 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. CRD scientists partner with manufacturing specialists for API synthesis in kilo-lab and pilot plant facilities, as well as provide support for technology transfer to Pfizer manufacturing sites and third party facilities.







The successful candidate as a part of the project team will partner closely with chemists and analysts to identify optimal technology (batch, semi-batch, continuous) and process operating conditions. They will then support technology transfer and scale up of the developed process in our pilot plant and commercial manufacturing facilities. Given the dynamic team environment, strong interpersonal and communication skills are essential.







**ROLE RESPONSIBILITIES**







+ 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.







**QUALIFICATIONS**



Required Education/Experience







+ BS/MS Chemical Engineering with a minimum of 7 years relevant chemical or pharmaceutical process development and technology transfer experience or PhD in Chemical Engineering with a minimum of 5 years of experience.







Required Technical Skills







+ A 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 Skills







+ Experience in working in a fine chemical or API manufacturing facility with a good knowledge of unit operations (batch and continuous) is strongly preferred.



+ 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.



+ Experience with laboratory development and large scale manufacturing of continuous synthetic organic processes is strongly preferred.







**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.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Other Job Details:**



Eligible for Relocation Package



Eligible for Employee Referral Bonus







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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