Scientist – Analytical Development, GPD

Location

• Durham, NC

Job Description

Are you an analytical scientist withextensive experience in routine analytical testingsupportingdevelopmentof new products?AstraZeneca’s Global Product Development (GPD) team is seekinga Scientist toexpandanalytical developmentcapabilitiesespecially with testing complex combination products withininhaledportfolio.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make theimpossiblea reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, thenyou’reour kind of person.

Within Global Product Development, we areseekingan experienced andmotivated Scientistwith astrongbackgroundand hands on experience with testing complex inhalation products,to driveAZ’s critical projects through development to commercialization.In thislaboratory based andimpactful role, you willsupport routine clinical lot releases, investigation work along with exposure to method development/optimization.You’llwork collaboratively acrossdifferent functionsto support keylicensetooperatetesting as well as complaint investigation.The role willbe inDurham, North Carolina, USA,butispart of AZ’s Global Product Development organization withadditionalsitesin Gothenburg,Sweden and Macclesfield,UK.

GPD’svision is towork in seamless ways that bring the best of our collective scientific capabilities to develop and deliver innovative and sustainablemedicines, making a meaningful impact on patients’ quality of life.Within the role,your expertanalytical supportwillrangefromearly phasedevelopmentworktolate-stagecGMPtesting.Experience with digital tools and AIis required tosupport overall vision for GPD.

The ideal candidate will be energetic and focused, with a can-do attitude and strong problem-solving and data analytics skills. You will join a highly collaborativeinternationalteamsupporting various projectsacrossdifferent developmentlifecycles.

Whatyou willdo:

• Manages own work to ensure that agreed targets are metin a timely mannerand toagreedqualitystandards andcommunicating progress appropriately. 

• Performs relevant experiments and interprets results based on a standardmethodologyin collaboration with formulation and/or device teams.

• Able toidentifyaberrant data and effectively communicatewithproject teams.

• Play a key role insupportingdevelopmentwork forautomation to manual methods forinhalation products such as Delivered Dose Uniformity (DDU), aerodynamic particle size.

• Support technical and scientific review of data generated by peers.

• Identifyand lead continuous improvement efforts to streamline laboratory operations andeliminatewaste, ensuring compliance with GMP/GxPexpectations. 

• Championlaboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis.

• Demonstrate an active interest inleveragingAI/MLandotherdata science tools to enhance analyticalresultsinterpretation and workflow performance.

Minimum Qualifications:

• Bachelor’s degree with 3+ years experience,or Master’s with 0 or more years experience, in Chemistry, Pharmaceutical Sciences, or closely relatedfield.

• Strong background in analyticalmethodologiesforinhalationdosage forms

• Hands onexperience working with HPLC/UPLC, moisture analyzer, and massspectrometryisrequired. 

• Proficiencywith analytical software such as Empower,Tiamo, ELNisrequired.

• Hands-onproficiencywith workflow optimization.

• Experiencewith statistical tools such as JMP is preferable.

• Excellent organizational, problem-solving, and collaborative communication skills.

• Experience working in a GMP/GxPregulated environment.

• Strong people, organizational, and communication skills (both written and oral)

Preferred Qualifications:

• Exposure to analyticalmethodologiesforportfoliosthat vary across modalities and/or dosage formats, including but not limited to oral solid and inhaled products.

• Familiarity or interest inutilizingdata science tools, including AI/ ML, to advance analytical interpretationand data flow.

• Experience collaboratingincross-functional global teams.

Why AstraZeneca

At AstraZeneca,we’rededicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.There’sno better place to make a difference in medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

SoWhat's Next

Are you alreadyimagining yourselfjoining our team? Good, because wecan’twait to hear from you!

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