Senior Project and Technical Lead (Associate Principal Scientist, Analytical) – On-Market Support (PT&D Chemical Development)

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceutical and the supply of healthcare services. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into actual 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 – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Drug Substance On-Market Technical

In Chemical Development we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to our patients. We combine people’s technical knowledge and understanding with their talent and drive to design, develop and optimise synthetic routes and analytical methods that deliver the active pharmaceutical ingredients of our medicines in a sustainable, commercially viable way. 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 development and delivery of our medicines.

We are currently recruiting for an Associate Principal Scientist (Analytical) to join our multi-skilled On-Market support group within Chemical Development. The group are dedicated to the lifecycle management of commercial active pharmaceutical ingredients (API) at AstraZeneca. We maintain continuity of supply, ensure license-to-operate and continue to deliver business value through optimisation of manufacturing processes, methods and supply chain design. AstraZeneca currently manufactures a high percentage of API externally at Contract Manufacturing Organisations (CMOs).

The responsibilities and requirements of the position are outlined below.

Key responsibilities:

As a very experienced analytical scientist, you will be responsible for leading our analytical technical contribution to maintain and optimise supply for one or more AstraZeneca commercial products meeting cost, quality and environmental targets for our customers. This includes:

• Leading the authoring and providing a significant contribution to the CMC components of regulatory submissions and preparation of successful query responses over the commercial life of a product to global markets.
• Providing expert technical input to change control and improvement activities at CMOs and internal AZ API manufacturing sites, linking understanding to assess the impact of changes on control strategy and analytical measurements
• Directing/influencing external organisations (CMOs) towards successful improvements of the manufacturing process including for example increasing process robustness and understanding, improving process efficiency, decreasing the analytical contribution to process variability and reducing environmental impact.
• Representing Chemical Development as lead analyst on CMC Project delivery and Global Supply Teams to ensure compliance/license to operate, security of supply and supporting improvements and changes to the supply chain, analytical methods and manufacturing process.
• Defining and communicating technical requirements for manufacturing process and equipment for input to selection of new suppliers.
• Executing or providing support and technical direction for any technical/experimental work required during investigation and definition of corrective and preventative actions.
• Coaching and developing junior colleagues, supporting them in reaching their full potential.
• Identifying and solving potential issues, and acting as an interface between departments.
• Ensuring, with respect to technical standards that changes to pharmacopeia are implemented at all manufacturing sites.
• Providing expert internal consultation on the commercialisation of pharmaceutical processes.
• Contributing to the development of the On-Market strategy to support AZ current and future portfolio, defining, and delivering continuous improvement plans.

All these activities will have a significant impact on the speed, quality, cost and environment impact of the AZ commercial portfolio, the overall success of the Supply Chain as well as ensuring the commercial viability and reducing carbon footprint of the medicine. The role, therefore, has a significant impact on both financial and reputational aspects of the business.

Essential Requirements:

• BSc/PhD level education in a relevant discipline and a significant number of year’s experience working within a Research & Development and Manufacturing environment, within the pharmaceutical industry.
• A good understanding of the overall drug development process from discovery through to launch.
• Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.
• A specialist in one or more related analytical areas or techniques and will therefore need to maintain that knowledge in order to provide expert advice.
• A thorough understanding of the principles and management of SHE and cGMP.
• Significant experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process or formulation analytical development, in the pharmaceutical industry.
• An understanding of key analytical techniques, including NMR, chromatography and mass spectrometry.

Skills and capabilities

• Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement.
• Ability to analyse and interpret complex situations and provide clear strategic directions for others.
• Excellent communication and strategic influencing skills across interfaces of discipline, culture, and expertise both internally and externally.
• Experience and skilled at facilitation at all levels.
• Proven problem solver with in depth technical skills.
• Demonstrate a high degree of personal credibility and end to end supply chain thinking.
• Proficiency in the use of statistics to understand data.
• The ability to confidently and successfully lead improvement projects.
• Experience of supporting commercial manufacture and working with contractors.
• Experience of late stage development with a background in an analytical skill group.

Please note applications MUST include your current CV and cover letter which details your key areas of strength / development and why you should be considered for the role