Associate Director – Process Engineering, Chemical Development
Location: Cheshire East
Job Type: Full time
Location – Macclesfield, UK
Competitive salary and benefits
Opening date – 22nd September 2022
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.
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.
AstraZeneca is at a critical phase in the journey to deliver our bold ambition; to improve the lives of 200 million patients and be a $50 billion company in 2025. We are on track to deliver 10 new medicines by the end of 2020, and we have one of the most exciting portfolios in the industry.
Pharmaceutical Technology and Development (PT&D) is the bridge that turns forward-thinking science into the medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines across all dosage forms– from supplies for use in early studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
We have a Team Manager role within the Chemical Development function at Macclesfield, for a talented, scientifically led individual to lead a team of Process Engineers.
You will lead a team of 8 to 10 Process Engineers that are responsible for:
The design, development and delivery of safe and efficient chemical processes for the production of clinical and commercial drug substance.
In conjunction with other skill groups, development of control strategies to ensure appropriate quality and robustness of clinical and commercial products according to current regulatory guidance.
Provision of process engineering contributions to manufacturing activities to supply drug substance.
Establishment of chemical processes for drug substance to enable Technology Transfer of manufacturing methods to internal and external manufacturing plants.
Design, commission and evaluation of plants, processes and new technologies for drug substance manufacturing activities.
Authoring, reviewing and approving of CMC documentation for clinical and marketing AZ product submissions
Identification and exploitation of innovative science, groundbreaking API technology and future plant or laboratory capabilities to improve process understanding and drug substance manufacture.
Contributing to the development of the Process Engineering Strategy to support our current and future portfolio and defining and leading continuous improvement plans.
Securing Intellectual Property and freedom to operate.
All these activities will have a significant impact on the speed, quality and cost of the AstraZeneca development portfolio, the overall success of PT&D 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.
In this role you will:
Coach your team and others for enhanced individual and team performance on an ongoing basis.
Ensure delivery of SHE and cGMP compliance, ensuring that all work is carried out with regard to AstraZeneca and external regulatory policies and standards.
Set the strategy and ensures the efficient delivery of the project portfolio within your area of responsibility.
Ensure technical work within own project and those outside of team meet required standards.
Build strong, collaborative relationships with Operations, Regulatory, Projects and Portfolio Management, Pharmaceutical Science, Supply Chain, at an operational level.
Enhance the reputation of the company in scientific circles by representing AstraZeneca, through external presentations, publications, membership of working parties and through academic collaborations.
Have a good understanding of the overall drug development process from discovery through to launch and commercialisation with an appreciation of how Chemical Development contributes to R&D and the broader business.
Likely to be a graduate or Ph.D with demonstrated ability within the business and pharmaceutical industry.
Have extensive understanding in the subject areas in Process Engineering, along with working knowledge of Process Chemistry, Analytical Science and Particle Science in order to contribute to a world class Chemical Development organization.
Have the experience or capability to lead and develop a team of scientists.
Have a detailed understanding of principles, applications and management of SHE and cGMP
Evidence of good communication skills and strong operational relationships with customers.
At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential!
Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be!
So, what’s next?
Complete your application before the below closing date.
This role is open from 22nd September 2022 and we welcome your application no later than 6th October 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.