Senior Formulation Scientist

Introduction to role:

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discoverydevelopmentand commercialisation of prescription medicines for some of the worlds most serious diseases. Butweremore than one of the worlds leading pharmaceutical companies. At AstraZeneca we are pioneering new frontiers byidentifyingand treating patients earlier working towards the aim ofeliminatingcancer as a cause of death.Our Macclesfield Campus is a vibrant hub of development and manufacturing excellencewhere your work will directlyimpactpatients worldwide.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

Global Product Development (GPD)is the bridge that turns brilliant science into real medicinesdesigningdevelopingand industrialising formulations and processes that enable robust commercial manufacture. We build the formulation manufacturing process and product understanding needed todevelopscale launch and sustain new medicines. Youwill collaborate in highly multidisciplinary teams spanning analytical science material science engineering biopharmaceuticsmicrobiologydevices/packaging clinical and supply chain.

We are seeking a Senior Formulation Scientistspecialising inparenteral dosage forms toadvancelate-stageprojectsthrough to commercialisation.In this roleyou will lead the rational design of robust patient-centric formulationsforsynthetic small moleculesandnew modalities includingoligonucleotidesandpeptides.You will collaborate closelywith process engineering and manufacturingteamson controlstrategies andcontribute to regulatory submissions and technology transfer. This role suits a scientist who is curious data-driven and collaborative with a passion fortransformingscience into manufacturable sterile products that meet patient and commercial needs.

Accountabilities:

• Lead the designdevelopmentand optimisation of high-quality sterileparenteralformulations (e.g. solution suspension lyophile) from Target Product Profile and patient needs through to commercial readiness.

• Collaboratewith process engineers on aseptic processing sterile filtration terminal sterilisation and lyophilisation cycle development to ensure manufacturability and scalabilityacrossclinical tocommercial phases.

• Author review and integrate highquality CMC documentation for clinical and marketingapplicationsincludingresponses to questions and regulatory interactions.

• Apply risk management tools tohelpidentifyrisks and to prioritise relevant development studies.

• Align formulationdevelopmentwith device and container closure strategy packaging analytics microbiology/sterility assurancebiopharmaceuticsclinical and supply chain requirements.

• Champion innovation continuousimprovementand knowledge sharing; contribute to publicationssecuring intellectual propertyand external collaborations whereappropriate.

• Maintainhigh standardsof 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 disciplineorsignificantrelevantindustrial 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 experienceindesigning sterile parenteral formulations with understanding from development throughtocommercialisation.

• Practical understanding of aseptic processing principles filtration compatibility extractables/leachables container closure integrity and lyophilisation fundamentals.

• Experience with peptides oligonucleotides or othernewmodalities.

• ExperienceinauthoringregulatoryCMC sections and articulating product and process control strategies; familiarity withpostapprovalchange management is a plus.

• Proficiencywith DoEstatistical analysismodellingand predictive tools to accelerate decisionmaking and derisk development.

• Strongcrossfunctionalpartnering and clear written/oral communication for technical and nontechnical audiences.

• Track recordof delivering to time qualityand 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 supportingformulationand device/primary container compatibility(e.g. subvisible particles aggregation container closure integrity extractables/leachables).

• Exposure to digital ways of working automated workflows or use of AIdriven insights to support robust formulation and process understanding.

• Experience working with CMOs/CROs and managing productive technical relationships.

• Experience oforal solid dosageformsdevelopmentand 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 -person working gives us the platform we need to connect work at pace and challengeperceptions.Thatswhy we work on average a minimum of three days per week from the office. But thatdoesntmeanwerenot 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 recognitionschemeand a competitive generousremunerationpackage.

Our mission is to build an inclusive andequitableenvironment. 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.

Where can I find out more

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Closing Date