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Associate Director (Analytical Chemistry), Early Chemical Development

AstraZeneca UK

Location: Cheshire East

Job Type: Full time

Posted

The most difficult thing is the decision to act, the rest is merely tenacity.
- Amelia Earhart

Associate Director (Analytical Chemistry), Early Chemical Development

Macclesfield, United Kingdom

Competitive Salary and Benefits

Closing Date: Tuesday 4th October 2022

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

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

Who we are

A high performing team, we are united and motivated by our shared purpose – to deliver life-changing medicines. We come to work each day to make a difference – to patients, society and our company.

What we do

Ultimately, our aim is to work towards a cure for some of the world’s most complex diseases. Whether that’s by shaping the patient ecosystem and focusing on outcomes, or by progressing potential medicines and accelerating their launch.

How we do it

The shared creativity through both internal and external collaboration unlocks challenges and brings new solutions.

Why we love it

This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

What you’ll do

Early Chemical Development is a world class CMC department with responsibility for early phase drug substance. The department’s responsibilities span from early engagement with Discovery Chemistry groups to the manufacture Phase II of clinical material, and its key skill areas include analytical chemistry, crystallisation, isotope chemistry, Large-Scale Laboratory (kilo-lab) manufacturing, process chemistry, process design, process engineering, route design and separation science.

You will lead a team of analytical scientists in Early Chemical Development contributing to the development and delivery of drug substance at all stages of early clinical development. You will manage the performance and professional development of staff, training and supervising both junior and senior staff.

You will work with your team, and in close collaboration with other skill groups and organisations, to ensure projects activities are delivered in line with the overall project timelines, scientific rigour and appropriate quality.

You will work with scientists in other functions to drive science and innovation within drug projects; this will include collaboration with scientists at our Cambridge, Boston & Gothenburg sites.

As a member of the Early Chemical Development Leadership Team, you will partner with other Team Leaders to contribute to strategic business development and manage resources to deliver the project portfolio to time, quality and quantity targets. You will work broadly across the company and externally, looking to implement new technologies and ways of working, plus interface, where necessary, with industry and regulatory bodies to keep abreast of industry trends.

Key Responsibilities:

  • Manage and ensure input of expert guidance to a team of analytical scientists to support development, manufacturing and clinical release activities of Active Pharmaceutical Ingredients performed both internally and externally at contract research organisations

  • Ensure work is performed in accordance with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Manufacturing Practice (GMP), ensuring standards are upheld and improvement and action plans delivered as required.

  • Coaching team member’s individual development as well as assess and reward their performance.

  • Contribute to the development of departmental goals and link them to team members’ individual goals.

  • Maintain an oversight of the project demands on the analytical team.

    • Evaluate the resourcing requirements for projects.

    • Monitor project progression and ensure appropriate resourcing is assigned to each project.

  • Lead cross-functional teams to define and implement improvement projects and strategic capability builds.

  • Review and approve analytical documentation such as stability protocols, methods, specifications and certificates of analysis plus CMC sections of regulatory submissions.

  • Seek out and share insights into new technology/novel product platforms and regulations and support their adoption within AstraZeneca.

Essential Criteria

  • BSc/PhD level education in a relevant discipline (for example Chemistry, Analytical Science) and a significant number of years’ experience working within a CMC analytical development organisation.

  • A good understanding of the overall drug development process from discovery and through the clinical phases.

  • Experience of clinical drug substance development with a background in an analytical skill group. including experience of a broad range of analytical activities, (e.g. method development and validation, stability, technology transfer).

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

  • Strong influencing, stakeholder management and prioritisation skills.

  • A thorough understanding and practical experience of the principles and management of SHE and cGMP, and a good knowledge of ICH guidelines.

  • An understanding of control strategies to define the long term requirements for ensuring the quality of drug substance

.

Desirable Criteria

  • Experience of performance/line management of teams.

  • Demonstrated strong scientific leadership.

  • 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.

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

  • Proven problem solver with in depth technical skills.

  • Experience of authoring CMC content for regulatory filings throughout the clinical development phases.

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

Why AstraZeneca

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.

So, what’s next?

Complete your application before the below closing date.

This role is open from Tuesday 20th September 2022 and we welcome your application no later than Tuesday 4th October 2022.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

20-Sep-2022

Closing Date

04-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.