Associate Director (Large Scale Laboratory [Kilo-lab]), Early Chemical Development, Pharmaceutical Science

Macclesfield, United Kingdom

Competitive Salary and Benefits

Closing Date: Friday 28th 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 of Phase II 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 be accountable for leading the Global AZ, Good Manufacturing Practice (GMP) kilo-lab internal manufacturing capability, the Large Scale Laboratory. Activities include:

• In-house manufacture of Active Pharmaceutical Ingredients (API) and support to design of commercially viable API manufacturing processes via the Large Scale Laboratory

• Ensuring successful operation, maintenance and compliance of the facility

• Continuous improvement of Large Scale Laboratory capability

• Exploitation of cutting edge manufacturing and scale-up technologies

• Collaboratively design, develop and implement best practice in API manufacture

You will lead a team of manufacturing scientists, chromatographers and maintenance support staff 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 project activities are delivered in line with the overall project timelines, scientific rigour and appropriate quality.

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:

• Accountable for the API Large Scale Lab deliveries, providing strategic leadership and technical direction

  • Ensuring successful operation, maintenance and compliance of the facility

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

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

• Manage and ensure input of expert guidance to a team of manufacturing scientists to support development, manufacturing and clinical release activities of Active Pharmaceutical Ingredients

  • Coach 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

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

• 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 development organisation

• The role holder should have a thorough working knowledge of the pharmaceutical industry to ensure that industry standards are applied, as well as possess an understanding of other relevant developments in Industry

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

• A thorough understanding and practical experience of the principles and management of SHE and cGMP

• Strong influencing, stakeholder management and prioritisation skills

Desirable Criteria

• 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

• 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

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 Monday 5th December 2022 and we welcome your application no later than Friday 23rd December 2022.

Applications must include your current CV, and a cover letter which presents your motivation and suitability for the role.

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

Closing Date

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.