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Senior Project and Technical Lead (Associate Principal Scientist) - Process Engineering, Chemical Development Technical Outsourcing

AstraZeneca UK

Location: Cheshire East

Job Type: Full time

Posted


Senior Project and Technical Lead (Associate Principal Scientist) - Process Engineering, Chemical Development Technical Outsourcing

Location: Macclesfield, UK

We have an exciting opportunity to join Chemical Development’s Technical Outsourcing team as a Senior Project and Technical Lead (Process Engineering)! In this role you will leverage internal expertise to drive high quality science in delivery of AZ projects through our strategic external partners.

The Company - AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical company where we not only focus on the discovery, development and delivery of life-saving medicines to our patients, but believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a great place to work and have a culture that inspires innovation and collaboration. We empower our colleagues to express diverse perspectives and at the same time feel valued, respected and rewarded for their ideas and creativity!

The Department - Chemical Development

In Chemical Development, we combine technical knowledge and understanding with the talent and drive to design, develop and optimise synthetic routes that deliver the active pharmaceutical ingredients (APIs) of our medicines in a scalable, sustainable, commercially viable way. We seek individuals who are determined to push the boundaries of science to deliver medicines to our patients. We believe in innovation and continuous improvement, working closely with colleagues in academia and across industry, to ensure that we apply the newest technologies and principles in the chemical processes we develop.

The Role

As an experienced Process Engineer with a proven track record of delivering pharmaceutical development projects in collaboration with Contract Development and Manufacturing Organisation (CDMO) partners, you will be responsible for leading the Process Engineering input to support external development and manufacture of several of our small-molecule investigative compounds.

You will provide Process Engineering leadership into pharmaceutical development delivery teams working with technical leads from other skill areas, project managers and quality assurance to achieve project delivery through our external partners.

You will play a key role in progressing our projects portfolio by supporting delivery of synthetic Route Design; Process Design and Optimisation; Preparation for Validation activities; Manufacturing of Drug Substance along with CMC Regulatory filing supporting clinical trial applications. To ensure success you will contribute to driving best practice ways of working to meet AZ standards and value drivers at our external partners, including effective knowledge management.

As a Senior Project and Technical Lead you will also mentor colleagues to support their development and delivery of the team’s projects portfolio, and make a significant contribution to establishing the team’s business processes.

Key responsibilities include:

  • Process Engineering Project Leadership for a small portfolio of development projects (Phase 2b/3 to commercial), providing expert input and challenge to Pharmaceutical (project) Teams. Contributing to definition and delivery of project plans and scope, identifying and solving potential issues, managing risks, and acting as an interface between departments

  • Technical leadership of process engineering activities delivered through external partners, driving application of internal expertise and cross-skill area collaboration to solve problems and explore new ways to deliver projects through the best science

  • Driving sustainability improvements using new and existing technologies

  • Modelling cost and PMI

  • Delivering CMC content or contributions to regulatory filings throughout the clinical development phase and commercial filings and preparation of successful responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMA, FDA) and other territorial requirements

  • Acting, when appropriate, as an authorised person accountable for the approval of documentation

  • Scientific leadership within the Process Engineering skill area and sharing learning across the department

  • Mentoring and developing colleagues, supporting them in reaching their full potential

  • Contributing to improving the capability of the Technical Outsourcing team to support the current and future project portfolio, defining and delivering continuous improvement plans

  • Collaboration with sourcing groups to provide feedback to partner CDMOs to continuously improve their performance and capability.

Profile:

  • Chemical Engineering, or similar, degree with a proven level of experience, delivering within mid to late-stage Research & Development in the pharmaceutical industry

  • Chartered Engineer status or able to demonstrate an equivalent level of experience

  • An understanding of key unit operations and technologies used in the development and manufacture of API

  • Solid knowledge of the overall drug development process from discovery through to launch with experience across late-phase development (Phase 2b/3 – Commercial)

  • Experience of leading small teams of people to deliver scientific projects with evidence of coaching and mentoring

  • Previous experience of supporting manufacture (clinical or commercial) and working with CDMOs is highly desirable

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

  • Experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process development, in the pharmaceutical industry

  • Excellent communicator able to provide and influence strategic direction across interfaces, and lead delivery of improvements.

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.

What's next?

Please apply with your current CV and a covering letter which presents your key areas of strength and why you should be considered for the role.

Competitive Salary & Benefits

Date Posted: 09.01.2023

Close Date: 30.01.2023

Date Posted

09-Jan-2023

Closing Date

30-Jan-2023

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.