Analytical Scientific Leader (Associate Principal Scientist)

AstraZeneca UK

Location: Cheshire East

Job Type: Full time

Posted

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Analytical Scientific Leader (Associate Principal Scientist)

Location: Macclesfield

Salary: Competitive Salary & Benefits

Date Posted: 02.09.22

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. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into 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 to join our growing analytical group within Chemical Development, we are looking for individuals who are dedicated to the development of clinical and commercial active pharmaceutical ingredients (API) at AstraZeneca across a range of small and large molecules.

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The Role

As an experienced analytical scientist with a proven track record of delivering pharmaceutical development projects, you will be responsible for leading a small group of analytical scientists in the technical and regulatory contribution to Active Pharmaceutical Ingredient (API) delivery. You will provide analytical leadership into pharmaceutical development delivery teams, providing strategic and technical leadership. You will also develop analytical scientists and deliver the Chemistry and Manufacturing Controls (CMC) aspect for projects to meet development timelines, working collaboratively with process chemists, engineers, project managers, 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.

Key Responsibilities:

  • To lead sophisticated projects, or a portfolio of 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)

  • To provide expert challenge to drug projects and role model positive behaviours in exploring new ways of working and scientific development

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

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

  • To deliver 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, EMEA, FDA) and other territorial requirements.

  • To deliver the validation requirements for commercial submissions

  • Mentoring and developing junior colleagues, supporting them in reaching their full potential.

  • Identifying and solving potential issues, and acting 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.

  • To 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.

Profile:

  • BSc/PhD level education in a relevant discipline and significant experience working within a Research & Development and Manufacturing environment, within 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 specialist in one or more related areas and will therefore need to maintain that knowledge in order to provide expert advice.

  • A detailed understanding of the principles and management of SHE and cGMP.

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

  • An understanding of key analytical techniques, including NMR, chromatography and mass spectrometry.

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 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 and end to end supply chain thinking.

  • Proficiency in the use of statistics to understand data.

  • The ability to confidently 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.

  • Application of risk based approaches in project delivery.

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Please note applications must include your current CV and a covering letter which presents your key areas of strength / development and why you should be considered for the role.

Closing date: 2nd October 2022

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Date Posted

23-Sep-2022

Closing Date

02-Oct-2022

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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