Why Patients Need You

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.

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

We are seeking an experienced scientist with excellent technical skills and project leadership credentials who is keen to learn more and join our dynamic and highly talented Analytical Research and Development group in Sandwich and lead our dissolution development group.

Job Focus

The successful candidate will have a proven track record in pharmaceutical development and extensive experience of dissolution testing of pharmaceutical products. They will lead the development and application of both dissolution and advanced in-vitro methods for the prediction of clinical performance in support of new formulation development and quality control.

They will lead the Sandwich dissolution team and work with cross-functional development teams collaborating with analytical chemists, and formulation scientists from across Pfizer's global organisation, applying their knowledge of dissolution science, advanced in-vitro tools, and the relevant global regulatory requirements to set the dissolution method development and dissolution regulatory strategy for Pfizer's solid oral drug product portfolio.

Responsibilities

· Provide leadership and develop the Sandwich Analytical Research and Development dissolution team.

· Provide exemplary support to projects and help drive development strategy for Pfizer's portfolio of solid oral products through all phases of clinical development through to commercial approval.

· Will be a lead author of sections of CMC regulatory documentation, e.g. IND, IMPD, CTDs.

· Provide presentations, training, and advice to others to share learnings and promote increased scientific, technical and strategic understanding around the area of dissolution science and clinically relevant invitro testing.

· Be aware of contemporary regulatory requirements for dissolution testing and provide input to emerging guidance on behalf of Pfizer in this key area.

· May represent the analytical department on global, cross-functional project teams and initiatives both internally and externally.

· Be a positive advocate for new technology, process improvements and for the application of computational tools and digital design approaches.




Qualifications

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

PhD degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field, is desirable but not essential.

Skills and Experience

· Sound knowledge of dissolution development and related contemporary global regulatory considerations.

· A team orientated person with significant experience leading teams in the pharmaceutical industry.

· A rational approach to problem solving with strong attention to detail and a desire to learn and grow their skills is essential.

· Candidates should be able to demonstrate a good knowledge of contemporary pharmaceutical development of small molecules and have a good understanding of global regulatory expectations, e.g. ICH guidelines.

· Team interaction is critical, and the colleague must be able to collaborate with and mentor peers as well as effectively interact with leaders as part of a multi-disciplinary team, thriving in a fast-paced environment.

· Experience in contributing to the authoring of external technical publications and/or CMC regulatory submissions is highly desirable.

· High level of practical competence with good laboratory safety awareness is expected.