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Pfizer

Makes cancer drugs, vaccines and other medicines

Senior Scientist Chemical Engineer - Chemical Engineer for API Manufacturing Process Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeGroton, CT, USA

About the Job

Requirements

  • A BS with at least 9 years of experience, an MS with at least 7 years of experience, or a PhD with 0 or more years of experience in Chemical Engineering is required.
  • Candidates with additional years of work experience will be considered for an appropriate level for their background.
  • Expertise in reaction engineering, including experience developing and validating kinetic models from experimental data, is required.
  • Excellent knowledge of chemistry and chemical engineering principles and a sound understanding of chemical reactor design, thermodynamics, transport phenomena, engineering statistics, and process modeling are required.
  • Outstanding laboratory skills, attention to detail, and the ability to solve technical problems are required.
  • The role requires the ability to work in a laboratory environment and perform experiments in a laboratory fume hood, as well as the ability to perform complex data analysis.
  • Candidates must be authorized to be employed in the U.S. by any employer; permanent work authorization in the United States is required.

Responsibilities

  • Apply chemical engineering principles to design and perform laboratory experiments to develop and optimize API manufacturing unit operations.
  • Assess scalability and robustness for API processes with an understanding of large-scale pharmaceutical manufacturing equipment, capabilities, and operations.
  • Evaluate, develop, and apply batch, semi-batch, and continuous-flow process technologies to deliver safe, efficient, and sustainable API processes.
  • Lead technology transfer of processes to internal clinical and commercial API manufacturing sites and external partners; time may be spent at the commercial launch site supporting process validation activities.
  • Apply process simulation and statistical tools to characterize the kinetic, thermodynamic, and transport phenomena affecting unit operations including 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 commercial manufacturing.
  • Champion development of new technology and digital tools to expedite new and existing workflows and capabilities.
  • Remain current with process engineering and chemistry literature; collaborate on and author external publications and present research at external conferences as applicable.
  • Contribute to preparation of the Chemistry and Manufacturing Controls section of the New Drug Application; participate in data verification, Pre-Approval Inspection preparedness, and post-submission query responses.

Desired Qualifications

  • Working knowledge of reaction modeling, property prediction, and process simulation tools, including gPROMS, Aspen, DynoChem, VisiMix, and COSMOtherm.
  • Experience designing, developing, and scaling continuous processes (flow chemistry).
  • A foundational understanding of organic chemistry.
  • Working knowledge of crystallization development.
  • Working knowledge of Design of Experiment studies and statistical analysis.
  • Working knowledge of analytical techniques including HPLC/UPLC, MS, PXRD, DSC, TGA, and NMR.
  • Working knowledge of applying in-situ analysis tools to process understanding, including FTIR, Raman, FBRM, and UV/Vis.
  • Computational fluid dynamics expertise in M-Star or Fluent.
  • Programming experience, including Python and/or Matlab.
  • Applied data science methods, such as machine learning and AI.
  • Experience automating laboratory equipment and processes, including use of LabView.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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