Senior Scientist: Process Engineering in Macclesfield

About Pharmaceutical Technology & Development (PT&D) and Global Product Development (GPD)

PT&D is the bridge that turns brilliant science into real medicines, spanning the entire value chain—from early toxicology and clinical supplies to technology that enables robust commercial manufacture. Within PT&D, GPD leads the late stage design and development of drug products across a range of dosage forms. We develop the formulation, manufacturing process, and scientific understanding needed to scale, launch, and sustain new medicines. You’ll collaborate in highly multidisciplinary teams with engineers and pharmaceutical scientists to advance life-changing medicines for patients.

We are seeking a Senior Scientist in Process Engineering with experience of parenteral product development (small molecule and new modalities, e.g. peptides) and/or oral solid dosage forms (tablets, capsules), who will help grow our engineering capability within Global Product Development.

As a senior scientist you will play a key role in leading the process engineering aspects of projects in late-stage development spanning an exciting portfolio of projects including:

• Lead engineering input for the design and development of robust manufacturing processes across parenteral and/or oral solid dosage forms.
• Lab-based process development: plan and implement lab-scale experiments to facilitate project decisions.
• Shape the scientific and technical direction of product development activities through process understanding and control.
• Define and optimise critical process parameters (CPPs) and integrate them into control strategies.
• Lead or contribute to technology transfer, risk assessment, process validation and scale-up.
• Apply modelling, simulation, digital twins and predictive tools to enhance process understanding.
• Solve key technical challenges with direct impact on current project delivery.
• Drive a culture of creativity, innovation and scientific excellence.
• Cross-functional collaboration: Contribute to integrated drug product development plans within a multidisciplinary team.

Requirements:

• PhD or Degree in Chemical Engineering in addition to relevant industrial experience.
• Hands-on experience developing parenteral (aseptic/sterile injectables) and oral solid dose products, including formulation and process definition.
• Experience leading in late-stage product development, technology transfer, scale-up and process validation.
• Fundamental understanding of control strategy and risk management with experience designing and implementing end-to-end control strategies, performed formal risk assessments and defined monitoring plans and CAPAs.
• Basic understanding of predictive science, artificial intelligence, modelling and simulation, with familiarity in AI/ML use cases, process simulation, and data pipelines.
• Ability to communicate complex technical content clearly; partners effectively with Operations, and external CMOs; authors high-quality technical reports and presents to governance.

Desirables:

• Experience with a range of unit operations e.g. aseptic processing, continuous manufacturing, granulation, compression, coating.
• Experience with regulatory authoring and defence.
• Experience with CMOs/CROs and outsourced development.

In Office Requirement:

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 five 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.

Competitive salary and benefits package on offer. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, a performance recognition scheme and a competitive, generous remuneration package.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.