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. The selected candidate will be part of Pfizer's Drug Product Design group, which is engaged in research to bring new, cutting-edge medicines to patients around the world.
As a post-doctoral researcher, you'll use science and technology to understand and mitigate the emergent risk of unacceptable levels of nitrosamines impurities in drug products. This research will require the development of robust analytical methods to detect trace levels of nitrosamines but more importantly this research will explore novel approaches to prevent or eliminate formation of nitrosamine impurities in pharmaceutical products. The post-doctoral researcher will evaluate the formation of nitrosamine impurities in stressed samples of active pharmaceutical ingredient ( API) based on predictive risks associated with structure and reactive potential of the API. Additionally, the drug product will be studied to assess the formation of nitrosamine impurities in the presence of commonly used excipients and mitigation strategies will be developed to avoid the formation of nitrosamine products.
This research investigation will enable the selected scientist to leverage existing scientific knowledge and expertise while creating opportunities for innovation in new areas, especially to evaluate the chemical reactivity of drugs and drug products to form nitrosamines. Identification of methods to either remove the formed nitrosamines or more challengingly develop novel approaches to prevent the formation of nitrosamines will be a major focus area of this research. Note that the post-doctoral position is a hands-in laboratory-based position. The selected candidate will work collaboratively with multidisciplinary scientists who will participate in defining strategies to mitigate the formation of nitrosamine impurities both in pure API and in the drug product. Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.ROLE RESPONSIBILITIES
The current research project is focused on evaluating the nitrosamine impurities in the drug substance and drug products. The goal is to enhance the mechanistic understanding of formation of these impurities accompanied by identifying mitigation strategies to prevent the formation of these impurities. The candidate will perform activities listed below but not limited to achieve the objectives of the project.
- To develop suitable analytical methods to detect and quantify nitrosamines in pharmaceutical products.
- To extensively use wet chemistry techniques such as gas and high-pressure liquid chromatography, spectroscopy, mass spectrometry and other modern analytical tools that would help identify and quantify nitrosamine in the drug substance and drug formulations.
- To design and execute experiments that can support either novel synthetic approaches for drug substance with minimal risk of formation of nitrosamines and/or develop drug products with excipients that would not induce generation of nitrosamine impurities.
- To develop quantification methods to determine the rate and percentage of the nitrosamine impurities in the presence of commonly used excipients in drug products.
- To regularly participate in discussions with several teams for data evaluation, analysis, communication, and documentation that includes presentations, reports, and publications. Note that the candidate will have the opportunity to present and publish the work at external conferences subject to clearance from the Pfizer legal group.
- To develop effective interactions within the Pfizer's global nitrosamine mitigation community and steering our knowledge in this important area of research.
- A doctorate degree in Medicinal or Organic or Analytical Chemistry or similar field with 0-2 years of laboratory-based research or equivalent experience.
- Expertise in methodology development and has successfully completed multistep syntheses.
- Strong knowledge of techniques related to purification and characterization of organic compounds.
- Expertise in reaction mechanisms and retrosynthetic analysis; ability to prioritize and simultaneously execute multiple potential synthetic options.
- Strong analytical experience that includes sample preparation and analysis using GC and HPLC chromatography. Fundamental understanding of systems such as OpenLab, Chromeleon, Empower or Excalibur.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS TRAVEL -
- Demonstrated ability to effectively work within a multi-disciplinary team of colleagues.
- Fundamental preformulation and formulation knowledge including understanding of solid-state properties of the drug substance and excipients.
- Comfortable working in a highly collaborative team environment.
- Ability to scientifically challenge others in a constructive manner and demonstrates exceptional team working skills (e.g., approachable and collaborative).
- Stays up to date with chemical literature and emerging synthetic methodologies and technologies.
- Proven track record of creative thinking and consistent delivery as demonstrated by publications and presentations.
10-15%OTHER JOB DETAILS
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Research and Development