Date open: 27/11/2023
Date close: 11/12/2023
We have a great opportunity for a Manufacturing Project Manager within our Projects, Process and Technology Team. You will work collaboratively within a team of Manufacturing Project Managers and Process Engineers to deliver the API (Active Pharmaceutical Ingredient), process data and scale-up learning to support the AZ clinical trial programme. You will need to be comfortable managing risk and working in a dynamic environment where no two days are the same.
Drug Substance Manufacture (DSM) is responsible for the internal manufacture of API for formulation development, pre-clinical and clinical development studies. Our Pilot Plant facilities, including batch reactors up to 6m3 and continuous manufacturing, are used to generate key scale-up learning and technology understanding for API process development. DSM also supports the rapid development of commercially sustainable processes by flexible accommodation and experimentation at scale. Drug Substance Manufacture is part of the Pharmaceutical Technology and Development function within Global Operations.
- You will be accountable for delivery of API manufacturing campaigns within the pilot plant, from procurement of raw materials to manufacture and delivery of the API, ensuring compliance with all SHE (Safety, Health and Environment) and GMP (Good Manufacturing Practice) standards. You will work closely with development chemists and engineers to transfer new manufacturing processes from the laboratory to the pilot plant, in particular generating and issuing process batch records to control production.
- You will need to develop a good understanding of API pilot plant manufacture, and the supporting SHE and GMP processes to enable safe and compliant manufacture. You will need to be able to work independently, and to lead interactions across several interfaces, including operational and engineering teams, development project and technical teams, supply chain teams and AZ support functions including SHE and Quality. You will also be expected to manage, improve and own relevant key business processes to ensure that we maintain our licence to operate and demonstrate excellence in SHE and GMP.
- You will also be required to facilitate problem-solving during manufacture, including Level 0, PPS (Practical Problem Solving) and deviation investigations. You are responsible for ensuring your work complies to internal and external regulations, including cGMP, SHE, fiscal and business procedures.
- You will also need to develop networks, in particular building and maintaining excellent working relationships with Chemical Development teams, while sharing scale-up learning and successes across the wider business.
- A relevant degree (or equivalent qualification) in a relevant scientific or chemical engineering field
- A confident and engaging communicator who can influence a variety of partners and stakeholders to drive success
- Comfortable working in a dynamic environment and managing risk
- Direct experience in pharmaceutical API manufacture or providing technical oversight to API manufacture
- Direct experience in clinical API pharmaceutical manufacture
- Experience in Lean manufacturing and problem-solving
- Experience with GMP / regulatory requirements
At AstraZeneca, we're dedicated to being an outstanding Place to Work. Where you are empowered to push the boundaries of science and spark your high-reaching spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and partnership, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
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. In addition, because this role directly supports an on-site manufacturing facility, we expect that you will be on site for the majority of the week. 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.
Competitive salary and benefits.
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.