Research into the Potential Formation of N-Nitrosamine Impurities in Drug Products9205215900?profile=RESIZE_584x

Post-Doctoral Position (initial period of 1 year)

About the job:

Why Patients Need You

Here at Pfizer we have a specific purpose – to find breakthroughs that change patients' lives. We are a patient centric company, guided by our four values: courage, joy, equity and excellence and our breakthrough culture lends itself to our dedication to transforming millions of lives.

Our Pharmaceutical Sciences Department, part of Pfizer Worldwide R&D, in Sandwich, UK plays a critical role in transforming patients’ lives around the world by providing the process technology, analytical methodology and support for the development and manufacture of medicines at all phases of clinical development.

We are seeking a post-doctoral scientist with excellent technical skills, who wants to learn more and add their expertise to our dynamic Analytical Research and Development group in Sandwich.

Job Focus

Nitrosamines are potentially toxic chemicals that can be formed in trace quantities in some drug products over time.  Recently there has been significant regulatory and industry interest in this potential problem, and this topic is likely to attract significant focus across the whole pharmaceutical industry over the coming years.  The purpose of this post-doctoral research position (with an initial term of 1 year) is to help Pfizer’s Pharmaceutical Sciences Small Molecule organization further improve our understanding of the factors that can affect the rate and extent of formation of nitrosamine degradants in solid-state drug products.  The successful candidate will have a strong track record in chemistry or analytical chemistry and will help drive this project through their insight and technical skills.

They will work with cross-functional development teams collaborating with organic chemists, formulation scientists, analytical chemists and material scientists from across Pfizer’s global organisation, applying a variety of analytical and physical characterization techniques (such as LCMS, ion chromatography, particle sizing and particle surface analysis) to help develop an industry-leading  mechanistic understanding of nitrosamine-forming processes in solid drug products.  Significant experience and expertise in one or more relevant technique would be advantageous, as would the ability to contribute to formulation design strategies. The colleague should also be able to learn new techniques and work with subject matter experts to solve this complex multidisciplinary problem.

 

This post-doctoral position is opportunity to develop a broad and deep knowledge spanning key disciplines within pharmaceutical sciences, working on a topic that is extremely important to the pharmaceutical industry over next several years.

 

Responsibilities

  • Collaborate with formulation and analytical scientists to study how the composition and solid-form properties of pharmaceutical products can affect nitrosamine formation.
  • Design and execute accelerated stability studies and use statistical and kinetic modelling approaches to analyse the data and understand the effect of factors such as temperature and humidity
  • Develop and apply quantitative trace analytical methods, especially LCMS, and apply a range of physical characterization techniques (such as laser diffraction, PXRD) as necessary.
  • Effectively collaborate with project team members in a multidisciplinary environment (e.g. from analytical chemistry, material science, formulation science and organic chemistry), including presenting data at project team meetings, critically reviewing experimental data and be actively involved in solving technical challenges.
  • Team interaction is critical, and the colleague must be able to collaborate with peers in a fast-paced, multi-disciplinary environment.
  • May author internal and external publications and collaborate in cross-industry consortia on this topic.
  • Provide presentations, training and advice to others to share learnings and promote increased scientific and technical understanding around their area of expertise.
  • Devise creative solutions for reducing nitrosamine formation and develop experimental protocols to critically evaluate their effectiveness.
  • Maintain written records of experimental work in accordance with GLP/GMP and departmental philosophies.

 

Qualifications

Honours or Masters degree in Chemistry, Analytical Chemistry or a related discipline with a high degree classification (e.g. equivalent of U.K. 1st or 2nd class).

PhD degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Material Science or a related field

Skills and Experience

  • A team orientated person with experience in a laboratory environment in the pharmaceutical industry or a closely related industry is highly desirable.
  • Excellent team collaboration and organisational skills and ability to work in a multidisciplinary environment are also essential.
  • A rational approach to problem solving with strong attention to detail and a desire to learn and grow their skills is essential.
  • Experience of running quantitative high sensitivity LC-MS preferred
  • Knowledgeable in the use of diverse computational, modelling and simulation tools would be highly beneficial.
  • A good appreciation of small molecule pharmaceutical development and an ability to apply scientific technical skills and knowledge to projects independently and proactively.
  • Able to demonstrate a good knowledge of contemporary analytical technologies.
  • Experience in contributing to the authoring external technical publications is desirable.
  • High level of practical competence with good laboratory safety awareness is expected.

 

Contact:    Interested individuals should contact roland.brown@pfizer.com for more information

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