Principal Scientist (Characterisation and Control Strategy)

Principal Scientist (New Modalities Characterisation and Control Strategy)

Location: Macclesfield or Gaithersburg

Competitive salary and benefits

Permanent opportunity

Make a meaningful impact on people’s lives with life-changing medicines

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a meticulous process of development, manufacturing, testing and delivery.

Pharmaceutical Technology and Development (PT&D)

PT&D designs and develops the active ingredients, the formulations, the processes and the devices that make up our Drug Products.

To support the development of the pipeline PT&D has established a New Modalities and Parenteral Development group. This group has accountability for developing the pipeline of both new modality projects and traditional synthetic molecules requiring parenteral delivery.

The New Modalities and Parenteral Development (NMPD) group was established to focus on the development of novel platforms (e.g. oligonucleotides, peptides, dendrimers and polymer drug conjugates, mRNA and nanoparticles). An exciting opportunity has arisen for an experienced Principal Scientist: New Modalities Characterisation and Control Strategy to perform an essential, scientific leadership role within the NMPD group.

The Role

This role focuses on analytical science as a key field that is essential for delivery of the diverse AZ portfolio. The role holder will be an established professional in the analysis and development of new modalities providing analytical leadership into pharmaceutical development teams delivering Chemistry and Manufacturing Controls (CMC) aspects for projects to meet development timelines.

As Principal Scientist, you will be encouraged to work collaboratively with process chemists, formulators, engineers, project managers, regulatory professionals, quality assurance and external partners to achieve a successful delivery. 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.

Key Accountabilities

  • 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 projects in the R&D and commercial portfolio. Lead control strategy and analytical method technology transfers to internal and external manufacturing sites. Using enhanced Control Strategies opportunities (e.g. PAT and RTRT) and drive implementation in projects

  • Developing regulatory strategy towards the delivering the CMC content, or contributions to regulatory filings throughout the clinical development phase and commercial filings, and preparation of successful query responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMA, FDA) and other territorial requirements

  • Major contributor for developing and implementing validation requirements for new products. Play a major role in the technical interactions with both internal and external manufacturing sites

  • Share scientific output and learning both within and beyond AstraZeneca. When appropriate, to publish papers and reviews in internationally recognised journals and/or present at appropriate conferences

  • 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

  • Use opportunities for utilising modelling, simulation and Artificial Intelligence to deliver productivity benefits

Required skills & capabilities

  • BSc/PhD level education in a relevant subject area or equivalent in experience

  • 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 Product Development contributes to this. Extensive experience of the fields within Product Development and how they work together to deliver the best outcomes

  • Significant experience in the development of analytical techniques used in the characterisation of and development of manufacturing processes for new modality medicines

  • Knowledge of quality risk management principles and ability take decisions with minimal data, applying risk based approaches in project delivery

  • Expertise and knowledge in the development of control strategies and analytical methods.

  • A proven track record in the authoring of regulatory submissions and in delivering technology transfer

  • A track record of engaging pharmaceutical industry to develop solutions and influence the external regulatory environment

  • Proven scientific leadership with publication and presentations at global events

  • 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 mentoring

  • Significant experience in working with external companies/partners to deliver business goals.

Please note applications must include your current CV and a cover letter.

Why AstraZeneca…

Working with medicines that address unmet needs fills us with pride! The potential to make people’s lives better is an incredible feeling! We get to support and positively impact local and global communities, from patients and their families to all of society.

Next steps…

Applications are open from 1st September to 19th September 2021.

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