Senior Trace Analysis Scientific Leader Chemical Development (PT&D)

Location: Macclesfield

Competitive Salary & Benefits

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person!

Pharmaceutical Technology and Development 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.

We are currently recruiting for an Associate Principal Scientist in Trace Analysis to join our analytical group within Chemical Development who are dedicated to the development of clinical and commercial active pharmaceutical ingredients (API) at AstraZeneca across a range of small and large molecules. As an experienced analytical scientist, you will have a proven track record of leading scientific strategy, and delivering new technology programmes.

To achieve this, you will have significant experience across post graduate academia and regulated industries (preferably Pharmaceutical) in developing trace methodologies employing a variety of chromatographic techniques GC, LC, IC, ICP alongside highly sensitive mass spectrometry (e.g. T of F, MSn ).  Knowledge of automated sample prep techniques or approaches would be an advantage.

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 our trace analysis strategies and associated analysis deliver material appropriate for use in clinical evaluation and commercialisation.

In this role you will be responsible for leading a small group of analytical scientists, to deliver the trace analysis requirements required for regulatory submissions and API delivery. You’ll provide analytical leadership in the area of trace analysis within Chemical Development, and will be a key member of the Global Trace Analysis Expert Working Group (EWG). You will develop analytical methodologies, generating data to deliver the trace analysis related Chemistry and Manufacturing Controls (CMC) aspects for projects (both API and drug product) to meet development timelines, working collaboratively with Chemical Development project analysts, Process Chemists, Engineers, Product Development, Quality Assurance and external partners, to achieve a successful delivery.

What you’ll do:

• Demonstrate scientific leadership, and strategic development of the scientific field of Trace Analysis, developing in conjunction with the Global Trace Analysis EWG, scientific capital and training strategies for AZ

• Deliver the trace analysis capability for PT&D to assess such analytes as mutagenic impurities (PMIs), and nitrosamines with limits of quantitation, and detection as low as single digit parts per billion

• Bring outward facing perspectives in addressing opportunities, (interface departments, specialist capabilities, regulatory advocacy)

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

• Provide scientific/technical leadership across the skill groups in resolving risks, identifying, learning to share across the department, and deliver regulatory submissions

• Take ownership for the quality and communication of science in projects, leading to high quality publications, and sharing of learning both within and external to AZ

• Ensure the delivery of related CMC content, or contributions to regulatory filings throughout the clinical development phase. As well as 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

• Deliver the validation requirements for commercial submissions

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

• Identify and solve potential issues and act as an interface between departments

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

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

All these activities will have a significant impact on the speed, quality and cost of the AZ 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.

What you’ll need

• BSc/PhD level education in a relevant discipline 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 analysis and identification of low level/trace impurities

• Significant experience of delivering CMC content or contributions to regulatory filings in the area of trace impurities such as mutagenic impurities, nitrosamines and or extractables and leachables

• 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 thorough 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 automation pertaining to some or all of these techniques

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

Skills & Capabilities

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

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

• Excellent communication and strategic influencing skills across interfaces of discipline, culture, and expertise both internally and externally

• Proven problem solver with in depth technical skills

• Demonstrate a high degree of personal credibility to lead a scientific area for AZ

• Proficiency in the use of statistics to understand data

• The ability to confidently and successfully lead improvement projects

• Experience of supporting knowledge transfers and working with contract manufacturing organisations

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

AstraZeneca can offer you a competitive salary, private healthcare, fantastic 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!

Please note applications should include your current CV and a covering letter which presents your your key areas of strengths and development, and your motivations for applying for the role.

Close Date: 27.06.21