Senior Scientist (New Modalities) – Analytical Science & Technology, Global Product Development, PT&D

Senior Scientist (New Modalities) Analytical Science & Technology Global Product Development PT&D

Location: Macclesfield UK

AstraZeneca is a global science-led patient-centred biopharmaceutical company focusing on discovering developing and commercialising prescription medicines for some of the worlds most serious diseases. But were more than a global leading pharma company. At AstraZeneca were dedicated to being a Great Place to Work and empowering employees to push the boundaries of science and fuel their entrepreneurial spirit.

In Pharmaceutical Technology and Development (PT&D) we are the bridge between brilliant science and innovative 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.

We are looking for a hardworking and motivated Senior Scientist (New Modalities) to join our Analytical Science & Technology (AS&T) team in Macclesfield (UK). In this role you will get the opportunity to strengthen our capabilities in material science applied to our next generation therapeutics. Your project-based scientific experience in soft-matter material science combined with a strong digital mindset and a drive to apply physical chemistry and biophysics to transform new modalities pharmaceutical development makes you a perfect candidate.

You will join a distributed team of material scientists who develop innovative new-modalities drug products. These products include peptides oligonucleotides siRNA-conjugates biologics and other complex modalities. They work across parenteral inhaled and oral platforms. Your role will be pivotal at the interface of raw materials drug product processes and in-vivo performance supporting drug projects from clinical through commercial phases. You will partner closely with formulators process engineers analysts and external collaborators to advance projects from latestage development through to commercialisation. You will operate at the interfaces and strengthen our understanding of how critical material attributes influence process robustness and product performance. Youll combine theory hands-on lab-based experimentation with modelling/simulation to uncover and control mechanisms of aggregation interfacial/surface properties self-assembly and soft matter/colloidal behaviour to turn insight into robust scalable designs.

Typical accountabilities:

• Lead and deliver material science activities and support drug product projects to ensure delivery to agreed milestones.

• Define and drive the identification and understanding of critical material attributes (e.g. drug substances excipients intermediate drug products) and their impacts on product performance and/or manufacture process robustness including impact of material variability drug substance-excipient interactions and stability.

• Design and conduct lab-based experimental activities to assess materials risks probe substanceexcipient interactions deliver robust material science plans and define materials controls strategies to support projects.

• Drive digital-first strategies and apply in silico approaches (e.g. molecular modelling generative models or simulations) to accelerate new modalities formulation decisions and predict critical parameters and their impact on product performance.

• Represent material science on new modalities projects and collaborate with analysts formulators and process engineers at the drug substancedrug product interface to integrate risk-based materials strategies into product design to drive innovation robustness and regulatory readiness.

• Engage with external partners to extend capability oversee outsourced work and support material characterisation and/or method transfer as needed.

• Author and review technical documentation including development reports and contributions to regulatory documents.

• Lead or contribute to the development of AI-tools supporting material characterisation methods and/or studies (e.g. enhance stability reduce aggregation etc.).

Required skills & knowledge

• PhD and/or BSc/MSc with significant industrial experience in a subject area relevant to SoftMatter Colloidal Physics Material Science Physical Chemistry Biophysics or related field.

• Demonstrated experience of techniques used to investigates material behaviours for large molecules (e.g oligonucleotides peptides biologics or polymers) specifically key physical properties including tunable viscosity droplets fusion aggregations size interface/surface science and soft matter & colloid characterisation.

• Demonstrated depth of knowledge in some characterisation techniques such as SEC-MALS DLS AF4 DSC-thermal calorimetry sub-visible particle characterisation surface tension fluorescence and rheology.

• Understanding of how to develop relationships between material attributes product processing and product performance.

• Proven ability to lead scientific activities in multi-disciplinary teams prioritise effectively and deliver to timelines and to a high-quality standard.

• Ability to tackle complex scientific problems and solving collaboratively with a positive outlook.

• Strong communication skills with the ability to explain complex datasets and challenges clearly to diverse stakeholders.

Desirable skills & knowledge

• Experience of solution and/or lyophilised new modalities drug products and familiarity with their manufacturing processes (e.g. freeze drying spray drying materials/device compatibility etc.)

• Experience of molecular dynamics modelling applied to study primary structure effects on higher-order structure to control binding self-assembly and stability. Familiarity with e.g. PEP-FOLD3 and homology modelling for 3D conformation prediction will be an advantage.

• Familiarity with complementary techniques such as NMR Raman fluorescence SAXS circular dichroism or nano-DSC.

• Experience with structure-informaticsfor prediction of aggregations.

• Experience working with outsourced partners (CMOs/CROs) including study oversight and tech transfer support.

• Experience contributing to CMC regulatory authoring (e.g. module/sections responses to questions) and/or supporting regulatory interactions.

• Evidence of scientific excellence through publications and/or conference presentations.

• Experience operating under GLP/GMP standards within a pharmaceutical industry or highly regulated environment.

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 challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Ready to make a difference Apply with your CV and cover letter and join us on this exciting journey!

Date Posted

Closing Date