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Scientific Leader Analytical Chemistry Technical Outsourcing (Associate Principal Scientist) – Chemical Development Technical Outsourcing

We have an exciting opportunity to join Chemical Development’s Technical Outsourcing team as a Senior Project and Technical Lead, Associate Principal Scientist, (Analytical Chemistry), where you will leverage internal expertise to drive high quality science in delivery of Astra Zeneca 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 with the talent and drive of our people 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

Scientific Leader Analytical Chemistry Technical Outsourcing (Associate Principal Scientist) – Chemical Development Technical Outsourcing

As an experienced Analytical Chemist 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 Analytical Chemistry input to support external development and manufacture of several of our small molecule investigative compounds. The role holder will provide Analytical Chemistry 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 by providing technical and strategic analytical leadership to deliver our development portfolio, by driving best practice and ways of working with our partners to support phase2/3 activities:

• Route design
• Process design
• Process optimisation
• Preparation for validation
• Manufacturing of drug substance
• Knowledge Management
• Developing process and analytical control strategies
• Regulatory filing supporting clinical applications.

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

Key responsibilities include:

• Technical leadership of analytical chemistry activities, delivered through external partners, driving application of internal expertise and cross-skill area collaboration to solve problems and exploring new ways of working to deliver projects through the best science.
• Collaboration with internal experts, sourcing and procurement to drive best practice and continuous improvement for outsourced analytical activities, ensuring delivery to AZ standards.
• Authoring regulatory files and preparation of successful responses to questions from health authorities.
• Coaching and developing colleagues, supporting them in reaching their full potential.
• Manage and approve, as appropriate, internal and external documentation to support project progression including release activities, stability studies, technical transfer documents and knowledge management documents in accordance with AZ standards.

Profile:

• BSc, MSc or PhD in Chemistry or Analytical Chemistry with a proven track record of analytical delivery for mid phase pharmaceutical development.
• Thorough understanding of the overall drug development process.
• Knowledge and practical experience across a range of analytical techniques, e.g. chromatography, mass spectrometry, nuclear magnetic resonance, with experience in method development and validation including technical transfer activities.
• Significant experience of developing analytical control strategies, authoring regulatory submissions and developing responses to questions from health authorities.
• Experience of leading small teams of people to deliver scientific projects with evidence of coaching and mentoring.
• Previous experience of supporting manufacture and working with CDMOs.
• A thorough understanding of the principles and management of cGMP and SHE.
• Excellent communicator able to provide and influence strategic direction across interfaces, and lead delivery of improvements.
• An established scientific reputation, e.g. publications in peer-reviewed journals, talks at international conferences, etc. is highly desirable.
• Knowledge of basic project management tools and relevant experience is highly desirable.

Please note applications must include your current CV and a covering letter which presents your key areas of strength and why you should be considered for the role.

Closing date: Sunday 23rd April 2023

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.