Senior New Modalities Project Leader

Macclesfield

Competitive Salary & Benefits

AstraZeneca is a global, innovation-driven Bio-Pharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

Pharmaceutical Technology and Development (PT&D) are the bridge which turns forward-thinking science, into medicines that help millions of people. We work across the entire value chain, crafting and delivering ingredients, formulations and devices required to support medicines – from supplies for use in early toxicology studies and clinical trials, to developing the technology to ensure drugs can be scaled up for manufacture.

As a modality analytical scientist with a proven track record of leading, and delivering pharmaceutical development projects. You will be responsible for leading a group of scientists, and the technical and regulatory contribution to large molecule API delivery. The role holder will be an established professional in the analysis, and development of new modalities (e.g. oligonucleotides, dendrimers, siRNA), and potentially peptides, providing analytical leadership into pharmaceutical development delivery teams, developing analytical scientists, to deliver the Chemistry and Manufacturing Controls (CMC) aspects for projects to meet development timelines.

As an Analytical Leader 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. The role encompasses some or all the following key drivers, depending on the stage of clinical development; speed, quality, cost, efficiency, measurement science, control strategy, robustness and understanding, to ensure quality of material and knowledge of processes for toxicology trials, clinical evaluation and commercialisation.

Typical responsibilities include:

• Leading sophisticated drug projects, or a portfolio of drug projects, from phase 2b/3 to commercial within analytical skill area, and to bring outward facing perspectives in addressing opportunities, (interface departments, specialist capabilities, external to AZ)

• Developing regulatory strategy towards the delivery of CMC content, or contributions to large molecule API 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, EMEA, FDA) and other territorial requirements

• Providing experienced challenge to drug projects, and role model positive behaviours in exploring new ways of working and scientific development

• Providing scientific/technical leadership in the area of New Modality analysis across the skill groups in resolving risks, raising the profile of the analytical group, through identifying learning to share across the department and deliver regulatory submissions

• Demonstrating scientific leadership and development of drug projects, representing Chemical Development on CMC Project and Global Supply Teams

• Delivering the validation requirements for commercial submissions

• Mentoring and developing junior colleagues, supporting them to reach their full potential

• Identifying and solving potential issues and act as an interface between departments

• Contributing to the development of Chemical Development to support AZ current and future portfolio, defining, and delivering continuous improvement plans

• Acting, as appropriate, as an authorised person accountable for the approval of documentation

What you’ll need;

• BSc/PhD level education in a relevant subject area and a significant experience working within a Research & Development and Manufacturing environment, within the pharmaceutical industry

• Significant experience in the development of analytical techniques used in the characterisation of and development of synthetic processes for large molecule API (e.g. oligonucleotides, peptides, dendrimers, siRNA)

• Significant experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process analytical development, in the pharmaceutical industry

• A good understanding of the drug development process from discovery through to launch

• Experience of technical supervision, coaching and mentoring or leading teams of people or scientific projects

• A detailed understanding of the principles and management of Safety, Health and Environmental issues and cGMP

• An understanding of analytical techniques, including NMR, chromatography, and mass spectrometry, and their application to analytical control, within large molecule API drug manufacturing processes

Skills and capabilities:

• Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement

• Ability to analyse and interpret sophisticated situations and provide clear strategic direction

• Excellent communication and influencing skills across interfaces of subject area, culture, and expertise both internally and externally

• Proven problem solver with in depth technical skills

• Demonstrate a high degree of personal credibility and end to end supply chain thinking

• Proficiency in the use of statistics to understand data

• The ability to expertly and successfully lead improvement projects

• Experience of supporting clinical and commercial manufacture and working with contract manufacturing organisations

• Experience of Phase 3 and commercial development with a background in an analytical skill group

• Ability to take decisions with minimal data, applying risk based approaches in project delivery

AstraZeneca can offer you a competitive salary, private healthcare, excellent training and development opportunities, and much more!

Join us on our journey of building a new kind of organisation, to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, ground-breaking cutting edge methods and bringing unexpected teams together.

Interested? Come and join our journey!

Close date: 21.06.21