Senior Formulation Scientist in Macclesfield

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. Our Macclesfield Campus is a vibrant hub of development and manufacturing excellence where your work will directly impact patients worldwide.

Global Product Development (GPD) is the bridge that turns brilliant science into real medicines, designing, developing and industrialising formulations and processes that enable robust commercial manufacture. We build the formulation, manufacturing process and product understanding needed to develop, scale, launch, and sustain new medicines. You will collaborate in highly multidisciplinary teams spanning analytical science, material science, engineering, biopharmaceutics, microbiology, devices/packaging, clinical and supply chain.

We are seeking a Senior Formulation Scientist specialising in parenteral dosage forms to advance late-stage projects through to commercialisation. In this role, you will lead the rational design of robust, patient-centric formulations for synthetic small molecules and new modalities, including oligonucleotides and peptides. You will collaborate closely with process engineering and manufacturing teams on control strategies and contribute to regulatory submissions and technology transfer. This role suits a scientist who is curious, data-driven, and collaborative, with a passion for transforming science into manufacturable sterile products that meet patient and commercial needs.

Accountabilities:

• Lead the design, development and optimisation of high-quality sterile parenteral formulations (e.g., solution, suspension, lyophile) from Target Product Profile and patient needs through to commercial readiness.
• Collaborate with process engineers on aseptic processing, sterile filtration, terminal sterilisation, and lyophilisation cycle development to ensure manufacturability and scalability across clinical to commercial phases.
• Author, review and integrate high quality CMC documentation for clinical and marketing applications, including responses to questions and regulatory interactions.
• Apply risk management tools to help identify risks and to prioritise relevant development studies.
• Align formulation development with device and container closure strategy, packaging, analytics, microbiology/sterility assurance, biopharmaceutics, clinical and supply chain requirements.
• Champion innovation, continuous improvement and knowledge sharing; contribute to publications, securing intellectual property and external collaborations where appropriate.
• Maintain high standards of data integrity, GMP awareness and laboratory safety; ensure documentation meets internal standards and external expectations.

Essential Skills/Experience:

• PhD in pharmaceutics, drug delivery, chemical / biochemical engineering or related discipline, or significant relevant industrial experience in drug product development.
• Strong grasp of how API physicochemical properties and excipient functionality influence solubility, stability, aggregation/particulates, tonicity, osmolality, and overall product performance.
• Proven experience in designing sterile parenteral formulations with understanding from development through to commercialisation.
• Practical understanding of aseptic processing principles, filtration compatibility, extractables/leachables, container closure integrity, and lyophilisation fundamentals.
• Experience with peptides, oligonucleotides, or other new modalities.
• Experience in authoring regulatory CMC sections and articulating product and process control strategies; familiarity with post approval change management is a plus.
• Proficiency with DoE, statistical analysis, modelling and predictive tools to accelerate decision making and de risk development.
• Strong cross functional partnering and clear written/oral communication for technical and non-technical audiences.
• Track record of delivering to time, quality, and compliance in a dynamic portfolio environment.

Desirable Skills/Experience:

• Exposure to sterile filtration sizing, integrity testing strategies, terminal sterilisation by heat or radiation where relevant, and aseptic risk assessment.
• Understanding of methods supporting formulation and device/primary container compatibility (e.g., sub visible particles, aggregation, container closure integrity, extractables/leachables).
• Exposure to digital ways of working, automated workflows, or use of AI‑driven insights to support robust formulation and process understanding.
• Experience working with CMOs/CROs and managing productive technical relationships.
• Experience of oral solid dosage forms development and manufacturing processes (e.g. continuous direct compression).

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 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.

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.