AstraZeneca Pharmaceuticals LP Principal Scientist - Project Expert Analytical in Macclesfield, United Kingdom
Pharmaceutical Technology and Development (PT&D) is the bridge that turns brilliant science 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 for use in early toxicology studies and clinical trials. We also develop and establish robust and reliable commercial manufacturing processes that ensure supply these life changing medicines to patients across the world.
An exciting opportunity has arisen for an experienced Principal Scientist: Project Expert Analytical to perform an essential, scientific leadership role within the Global Product Development group at our Macclesfield site. This role focuses on analytical science as a key discipline that is essential for delivery of the AZ portfolio. As Principal Scientist, you will drive drug product development strategy incorporating key scientific and technology requirements. You will provide strong technical expertise along with substantial development experience to establish and optimise commercial supply for AstraZeneca development projects meeting quality, cost and time targets for our customers.
Provide scientific leadership and coaching to multi-disciplinary teams of pharmacists, chemists, analysts, process engineers and biopharmaceutics scientists to develop robust commercial control strategies and analytical methods.
Provide expert internal input to strategies for drug product projects in the R&D and commercial portfolio
Lead control strategy and analytical method tech transfers to internal and external manufacturing sites.
Major contributor to regulatory filings supporting new drug products and line extensions.
Major contributor for developing and implementing validation requirements required for new products.
Play a major role in the technical interactions with both internal and external manufacturing sites.
Lead root cause identification for OOS, OOT and deviations. Provide technical leadership for experimental work required during investigation and definition of corrective and preventative action.
Share scientific output and learning both within and beyond AstraZeneca
A visible role model for scientific leadership across and beyond PT&D
A coach and leader of scientific staff leading networks and communities of practice where appropriate
An innovator that implements new methods, products, technologies or ways of working
Create, drive and support a culture of scientific excellence.
All these activities will have a significant impact on the speed, quality and cost of the AZ R&D and commercial portfolio, the overall success of the supply chain as well as ensuring the commercial viability of the medicine. The role, therefore, has a significant impact on both financial and reputational aspects of the business.
Required Skills & Knowledge
BSc/PhD level education in a relevant discipline.
Significant number of years’ experience working within a Research & Development and Manufacturing environment, within the pharmaceutical industry.
A detailed understanding of the drug development process and how Global Product Development contributes to this.
Extensive experience of the disciplines within Global Product Development and how they work together to deliver the best outcomes
Expertise and knowledge in the development of control strategies and analytical methods.
A proven track record in the authoring of regulatory submissions.
A proven track record in technology transfer.
A thorough understanding of the principles and management of SHE and cGMP
Demonstration of collaborative and multi-disciplinary team working to deliver a range of science and technology and drug project objectives.
Proven experience in developing the capability of individuals and teams of scientists and in supporting project teams through effective coaching and technical mentoring.
Skilled in effective communication across a range of skills and different hierarchy levels.
Significant experience in working with external companies/partners to deliver business goals.
Working knowledge of other departments who contribute to the drug development process
Please note applications must include your current CV and a cover letter.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.