Analytical Development Team Manager
Make a positive impact, in a team where it means more
Disciplined thinkers and doers, we thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. A place where anyone is supported to step up and lead, and everyone has the freedom to take ownership and drive outcomes forward.
If you have the passion and the drive to accelerate growth and make people’s lives better – then this is the place for you.
Working with medicines that address unmet needs fills us with pride. The potential to make people’s lives better is an incredible feeling. We get to support and positively impact local and global communities, from patients and their families to all of society.
The Macclesfield site is our second largest manufacturing site and the largest UK based campus, from which our medicines are manufacture, packaged and distributed to over 130 countries globally. People are at the very heart of AstraZeneca and the facilities around site support this. You will find an onsite gym, restaurants, parking, on-site holiday childcare and much more!
The business area
The role holder will contribute to the New Modalities & Parenteral Development (NMPD) department in Pharmaceutical Technology & Development (PT&D), leading a team that contributes to the speed, quality and cost of the AstraZeneca drug development portfolio.
The Analytical Team Manager will define and execute drug product analytical development activities through late stage clinical trials and into commercial operations in accordance with defined standards. This will mean leading on development of innovative & robust control strategies, founded on strong science along with an appreciation of current regulatory context.
As a strong communicator, you will collaborate across skill areas to develop holistic control strategies that consider all elements of drug product quality & safety by exploitation of cutting edge analytical technologies.
Technology transfer to CROs or AstraZeneca laboratories will be coordinated by the post holder. You will participate in the generation of high quality regulatory CMC documentation to acquire clinical and marketing application approval.
You will also be looked upon to make an active contribution to the extended Leadership Team and the development of the organisation.
The role holder will lead a group of approximately 10 to 12 scientists.
Owns the local implementation of the NMPD/PT&D strategy and change plans.
Leads the implementation of new practises that enable the group to achieve flexibility, agility, efficiency and delivery.
Ensures delivery of SHE and cGMP compliance, ensuring that all work is carried out with regard to AstraZeneca and external regulatory policies and standards.
Operates confidently to build an organisation prepared for future challenges and change.
Ensures the delivery of the project portfolio within their area of responsibility.
Develops solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision and analysis.
Coach, motivate, encourage and develop all staff.
Essentials for the role:
Have a good understanding of the overall drug development process from discovery through to launch
Excellent working knowledge of the Product Development Process
PhD or a BSc/MSc in combination with a number of years experience within the business and industry
Have sufficient understanding of the analytical science subject area
Experience in, or exposure to, multiple fields in CMC and related functions (e.g. Discovery, Operations and Clinical)
Have the experience or capability to lead and develop and mentor a team of scientists
Have a thorough understanding of principles, applications and management of SHE and cGMP
Project management understanding and/or experience
We are active players in growth and evolution. It’s a clear long-term strategy and we see the role we play. There’s a great opportunity to influence how we develop supply chains, promoting a Lean mindset and leading on sustainability.
Are you ready to bring new ideas and fresh thinking to the table? Excellent! We have one seat available and we hope it’s yours.
Applications are open from 6th July to 20th July 2021
Competitive salary and benefits
- Salary 50000-71000