Biopharmaceutics Principal Scientist

Location: Macclesfield, UK

Permanent opportunity

Competitive Salary & Excellent Benefits

Follow the science to explore and innovate

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases. With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength!

Business area

An exciting opportunity has now arisen for a Senior Scientist or Associate Principal Scientist (dependent on experience) to join our Global Product Development team in New Modalities and Parenteral Development (NMPD), Macclesfield, UK.

NMPD turns innovative drug candidates into medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines; from supplies used in clinical trials, to developing the technology to ensure drugs can be scaled up for commercial manufacture.

The role

In NMPD, you will be a key member of a project team responsible for the biopharmaceutic characterisation of drug products including conventional dosage forms as well as enabling formulations, nanomedicines and advanced drug delivery technologies across non-oral delivery routes.

We will rely on you to bring a strong understanding of biopharmaceutics and relevant analytical background to the team to enable a mechanistic understanding of drug product performance to be developed.

The role will work cross functionally with multiple internal and external interfaces (Manufacturing, Chemical and Formulation Development, Regulatory, Quality Assurance and Academia), supporting drug projects from the early clinical phase through to commercial filings.

Key Accountabilities

  • Application of specialised in vitro, in vivo and in silico techniques to enable comprehensive evaluation of drug substances and drug products to elucidate their critical quality attributes driving human exposure.

  • As a member of a cross-skilled team, play a lead role in the identification, evaluation and implementation of cutting edge capabilities in the field of biopharmaceutics to build and improve product characterisation for non-oral administration routes, with standard and advanced drug delivery systems

  • Developing links with external collaborators to drive novel science.

  • Working with specialists in areas such as analytical science, formulation, pharmacokinetics and pharmacometricians to build product understanding and a relationship to in-vivo performance.

  • Developing robust control strategies to support projects.

  • Be a project Biopharm representative on multiple projects in the AstraZeneca portfolio

  • Be involved in the Biopharm local and global networks and participate in the development of science and technology in this field

  • Authoring of regulatory documentation in support of clinical trials and the commercialization of new products.

Required Skills & Knowledge

  • Degree (BSc, Master, or PhD) in Chemistry, Analytical Sciences, Pharmaceutics, Biopharmaceutics, DMPK, Drug Delivery, or a related subject or equivalent in experience

  • Good understanding of the relationship between in-vitro release and in-vivo performance.

  • The ability to tackle complex scientific problems and troubleshooting of project issues.

  • Excellent communication and key business partner engagement skills, and the ability to discuss complex ideas in a simple, easy to understand, way.

  • Strong team working abilities with a track record of multi-disciplinary working.

  • Modelling and simulation experience as either a developer or a user in the field of biopharmaceutics.

Preferred Skills & Knowledge

  • Practical experience of developing robust in-vitro release methodologies for standard or advanced drug delivery systems.

  • Understanding of biology and biopharmaceutics, pharmacokinetics and pharmacometrics and physical chemistry.

  • Use of GastroPlus, Simcyp, Matlab or WinNonLin.

  • Knowledge and industrial experience of pharmaceutical development and regulatory requirements, including parenteral drug development.

  • Strong influencing skills and prioritisation skills to ensure efficient project delivery.

  • A track record of scientific excellence in terms of publications and/or conference presentations.

Why AstraZeneca?

If your passion is science and you want to be part of a team that makes a bigger impact on patients’ lives, then there’s no better place to be.

Next steps…

Are you ready to bring new ideas and fresh thinking to the table? Excellent! We have one seat available and we hope it’s yours.

Applications are welcome from 23rd July to 8th August 2021

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