Technical Outsourcing Director

AstraZeneca UK

Location: Cheshire East

Job Type: Full time

Posted

Be brave, not perfect.
- Reshma Saujani

Technical Outsourcing Director

Macclesfield

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

Here you’ll have the chance to create a significant 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 sophisticated diseases.

Pharmaceutical Technology and Development (PT&D) is the bridge that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices for new medicines while providing expert technical support to all AZ’s commercial drug substances and products to ensure we optimally supply medicines to patients.

We now have an opportunity for a Technical Outsourcing Director to join our team. Responsible for a multi-functional team of up to 10 internal scientists that provide key technical support and project management for externally resourced Drug Substance late phase projects. This will require working internally and externally to deliver high quality science supporting: Route Design; Process Design and Optimisation; Preparation for Validation activities; Manufacturing of Drug Substance along with CMC Regulatory filing supporting clinical trial applications.

What you'll do:

Create and continuously improve the overall operating model for the team, including business processes for outsourced development.

Coach direct reports and others for enhanced individual and team performance on an ongoing basis.

Set the highest standards for technical work and support for projects, which are delivered externally, but supported internally. Provide input into portfolio decisions and manage workload and priorities of internal team.

Review and approval of CMC regulatory submissions to support clinical programmes.

Ensure effective knowledge management of data and learning generated externally for either transfer back to Chemical Development for internal development or to enable technology transfer to a commercial supplier.

Identify, evaluate, select and on-board new suppliers (in collaboration with Sourcing and Procurement colleagues), resulting in strong external relationships.

Identify issues and gaps in CDMO capability and work externally to resolve these. Acquire knowledge from external CDMO’s to apply back into AstraZeneca internally resourced projects.

Deliver SHE compliance, ensuring that all work is carried out with regard to AstraZeneca and external regulatory policies and standards.

Enhance the reputation of the company in scientific circles by representing AstraZeneca, through external presentations, publications, membership of working parties and through academic collaborations.

Skills & Experience

  • Good understanding of the overall drug development process from discovery through to launch with an appreciation of how Pharmaceutical Development contributes to R&D and the broader business.

  • Ideally a Graduate or Ph.D with significant experience within the business and industry (or equivalent)

  • Sufficient understanding in the techniques of Process Chemistry, Analytical Chemistry, Process Engineering, Right Particle.

  • Experience of (or capability to) lead and manage a team of scientists.

  • Experience of project leadership and authoring/review of CMC regulatory submissions to support clinical programmes.

  • Thorough understanding of principles, applications and management of SHE and cGMP.

  • Good communication skills and strong operational relationships with customers to inspire change.

There are so many fantastic employee benefits that AstraZeneca offer! AstraZeneca can offer you a competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.

What's Next...

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!

We look forward to receiving your application no later than Friday 7th October

Competitive Salary and Benefits

Open Date: 16/09/2022

Close Date: 07/10/2022

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Date Posted

16-Sep-2022

Closing Date

07-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.

You’ve got this!