Senior Analytical Project Leader

Location: Macclesfield

Competitive Salary & Benefits

Make a more meaningful impact to patients’ lives around the globe

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

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

As an experienced analytical scientist, with a proven track record of leading and delivering pharmaceutical development projects, you will be responsible for leading a group of analytical scientists, and the technical and regulatory contribution to API delivery. You’ll be an established professional in the development of control strategies for small molecule API, including the analysis and specification setting of raw materials, intermediates and API, providing analytical leadership into pharmaceutical development delivery teams, developing analytical scientists, to administer the Chemistry and Manufacturing Controls (CMC) aspects for projects to meet development timelines.

As an Analytical Leader we’ll encourage you to collaborate 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, control strategy, robustness and understanding, to ensure quality of material and knowledge of processes for toxicology trials, clinical evaluation and commercialisation.

What you’ll do:

• Lead 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)

• Develop A regulatory strategy towards the delivery of CMC content, or contributions to 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

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

• Provide leadership 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

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

• Deliver the validation requirements for commercial submissions

• Mentor and develop junior colleagues, supporting them to reach their full potential

• Identify and solve potential issues, acting as an interface between departments

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

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

 Essential Criteria:

• BSc/PhD level education in a relevant field and 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 elaboration of regulatory control strategies, the characterisation of and development of synthetic processes for small molecule API

• 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 overall drug development process from discovery through to launch

• Experience of technical supervision, coaching and mentoring or leading small 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 key analytical techniques, including NMR, chromatography and mass spectrometry and their application to analytical control within 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 strategic influencing skills across interfaces of field, culture, and expertise both internally and externally

• Proven problem solver with in depth technical skills

• Demonstrates 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, 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