Product Lead - Manufacturing Science & Commercial Supply, Chemical Development

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, 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 and ultimately continuing to ensure that these medicines can be manufactured for supply to patients. Within PT&D, 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 deep technical knowledge and understanding with their talent and drive to design, develop and optimise synthetic routes 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 processes we develop. Chemical Development are responsible for development, launch and lifecycle management of our commercial active pharmaceutical ingredients (API) at AstraZeneca. We are committed to right first-time technology transfer and process validation alongside maintaining continuity of supply, license to operate and continuous improvement to deliver business value through optimisation of manufacturing processes and supply chain design. AstraZeneca currently manufactures a high percentage of API externally at Contract Manufacturing Organisations (CMOs) and our internal manufacturing landscape is evolving. We are looking for a Product Lead to enable commercialisation and continuity in on-market support., As an experienced scientist, you will provide technical leadership to project teams to ensure we maintain and optimise supply for AstraZeneca's commercial products meeting cost, quality, and environmental targets for our customers. This will require you to:

• Collaborate across the department and function to ensure the delivery of right first-time technology transfer and provide expertise in process validation.
• Represent Chemical Development as a Product Lead on a Pharmaceutical Team to ensure supply of API as well as supporting improvements and changes to manufacturing processes.
• Provide in-depth understanding of the scientific and technical aspects of manufacturing processes, including the equipment, materials, and methods used.
• Deliver scientific leadership through identification and implementation of change programmes to improve robustness, cycle time, cost, and environmental targets.
• Provide scientific leadership to change assessments and deviations.
• Contribute to the CMC components of regulatory submissions (both new submissions and post-approval variations) with preparation of successful query responses over the commercial lifecycle.
• Ensure delivery of SHE and cGMP compliance, with all work carried out 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.
• Coach and mentor less experienced colleagues.
  
  PhD or BSc/MSc in chemistry, engineering or analytical or equivalent
• Experience working within a Research & Development and/or Manufacturing environment within the pharmaceutical industry.
• A thorough understanding of scale-up operations used in manufacture with knowledge of validation principles and experience in executing validation protocols to ensure compliance with regulatory requirements.
• Understanding of regulatory guidelines and the ability to ensure that manufacturing processes adhere to our regulatory files.
• Commitment to continuous improvement methodologies to enhance manufacturing efficiency and drive business value.
Desirable Skills/Experience:
• The ability to develop and analyse multiple solutions to problems.
• The capability to coach and drive performance and development among your peers.
• Project management: skills in project management to oversee the technology transfer, optimization, and other activities coupled with the ability to assess and manage risks.
• Ability to challenge and innovate, bringing new solutions and opportunities for chemical development.
• Strong analytical and problem-solving skills to identify and address issues in manufacturing processes and find effective solutions.
• Excellent communication skills, with the ability to communicate across interfaces of scientific disciplines, culture, and expertise both internally and externally.
• The ability to confidently participate in, and potentially lead, improvement projects.
• Proficiency in collecting and interpreting data to make informed decisions.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Be welcomed into our inclusive network of diverse and high-performing teams. Have the support, trust, and respect to thrive here. For those with a shared drive and passion for impacting people's lives, experience a sense of belonging like no other.