Senior Scientist-Analytical Project Lead, Global Product Development

SeniorScientist Analytical Project Lead Global Product Development

Location Durham NC USA

Job Description Are you ready to shape the future of medicinespioneering technical and scientific breakthroughs that transform patient lives Are you passionate about converging your analytical science experience and leadership skills Then this role might be the right one for you!

Pharmaceutical Technology and Development (PT&D)sitswithin Operations and is the organization that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain designing and delivering active ingredients formulations and devices for new medicines and providing expert technical support to all AstraZeneca commercial drug substances and products to ensure we successfully supply medicines to patients.

Within Global Product Development (GPD) we areseekingan experienced and innovative Analytical Project Lead based in Durham North Carolina. Our vision is to transform product designdevelopmentand characterization to enable delivery of new medicines to this role you will leadanalyticalstrategy and delivery for oral solid dosage (OSD) forms and as needed inhaled and/or parenteral products from early development through clinical supply and toward commercialization.

Acting as the analytical project/skill lead you will partner across formulation engineering biopharmaceutics manufacturing QA and Regulatory to deliver robust methods efficient control strategies andsubmissionreadydocumentation. You will also helpestablishandoptimizeOSD laboratory capabilities at the Durham site champion laboratory automation and encourage adoption of modern data analytics and AI/ML tools to accelerate development and interpretation.

We work on average a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility.

What you willdo:Weare lookingfor someone who combines robust knowledge of pharmaceutical development with a strong analytical background and critical thinking to generate decisive data and control strategies. You are comfortable aligning partners setting direction and resolving ambiguity to keep programs on track and meet achievements. You enjoy driving learning between projects and introducingnew technologiesand ways of working.

Responsibilities include but are not limited to:

• Project leadership: Act as analytical skillleadto secure major drug product deliveries applying ariskbased flexible approach to prioritization resources and timelines across modalities and dosage forms; integrate analytical plans with global teams and external partners/CMOs.

• Analytical strategy & control: Define and ownaphaseappropriate analyticalcontrol strategy aligned with CMC expectations across clinical phases; harmonize methods and embed lifecycle management to ensure robust efficient control.

• Method development & validation: Design develop validate transfer andlifecycle manageanalytical methods for OSD (e.g. HPLC/UPLC LCMS dissolution impurity profiling stabilityindicating capability); establish scientifically supported system suitability specifications and fitforpurpose sample preparation; ensure readiness for GMP execution with clear documentation and analyst guidance. Support inhaled and/orparenteralmethods as needed.

• Characterization & performance: Lead drug product characterizationcomparabilityand stability programs; directforceddegradationnstudies; for inhaled products whererequired support aerodynamic performance assessments (e.g. impactor analysis).

• CMC & regulatory: Author and review analytical CMC content for IND/IMPD/NDA/MAA; prepare validation reports method transferdocumentsand specifications; lead responses to regulatory queries and supportshelf lifeassignment withappropriate statistics.

• Crossfunctionalcollaboration: Work closely with formulators engineers supply and manufacturing sites QA Regulatory and external partners/CMOs to integrate analytical deliverables into project plans and clinical manufacturing.

• Durham lab capability & technology:Champion laboratory automation for sample preparation methodexecutionand data analysis underGxPcontrol.

• Problem solving: Lead complex investigations rootcauseanalysesand dataintegrity assessments; apply structuredproblemsolving(e.g. Six Sigma) and statistics to drivetimelyresolution and preventive actions.

• Digital data & innovation: Apply DoE and statistics for method robustness and understanding; use ELN/CDS and statistical tools; promote AI/ML chemometricsand predictive analytics to enhance interpretation specificationsettingand development speed; enable learning and standardization across projects; chip in to patenting and/or publishing.

• Quality & governance: EnsureGxPcompliance where applicable data integrity rigorous study design and clear communication to governance bodies.

Minimum Qualifications:

• Bachelors (12 years) Masters (6 years) or PhD (or equivalent experience) in Analytical Chemistry Pharmaceutical Sciences BiochemistryBiotechnologyor related field.

• Significant experiencein pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications.

• Demonstrated experience in analytical development for oral solid dosage forms;additionalexperience with inhaled and/or parenteral products preferred.

• Consistent recordleading teams and/or scientific projects within a global organization and with external partners/CMOs; ability to influencecrossfunctionalstrategies.

• Strongproficiencywith chromatographic techniques (HPLC/UPLC; LCMS) dissolution and complementary methodologies; for inhaled products familiarity with aerosol performance characterization is a plus.

• Handson experience in method development (including use of supporting software) validationtransferand lifecycle management under ICH guidelines andphaseappropriateframeworks.

• Experience authoring analytical CMC content for submissions and responding to regulatory queries across clinical development.

• Experience working in a GMP/GxPenvironment; familiarity with instrument/equipment qualificationcalibrationand maintenance expectations.

• Excellent communication customer management and influencing skills; ability tooperateconfidently and collaboratively across globalcross-disciplinaryenvironments.

• Demonstrated ability to troubleshoot technical challenges and drivedatadrivendecisions.

• Fundamental digital and data capability relevant to analytical development including:

• Proficiencywith multivariate experimental design and basic DoE concepts for method and process understanding

• Working knowledge of statistics for analytical science (e.g. regression ANOVA capability/variation analysis stability trending OOS/OOT investigation)

• Practical use of ELN/CDS and statistical software (e.g. JMP or Minitab) for data analysis and reporting

Preferred Qualifications

• Strategic chromatographic and separation science leadership: define orthogonal method suites (e.g. RP HILICionexchange SEC SFC CE) to secure impurity resolution and stabilityindicating capability; apply LCMS(/MS) for structure confirmation and quantitation; use multidimensional LC and targeted DoE to accelerate development and set robust specifications; harmonize methods across sites with clear comparability criteria; embed lifecycle management and coach teams through complex separations (e.g. peptides oligonucleotides challenging matrices).

• OSD focus:Support with establishingequippingandoptimizingOSD testing capabilities at the Durham site. Experience with solidstate characterization (e.g. XRPD DSC TGA) and dissolution strategy. Inhaled support: advanced performance assessment techniques aerosolcharacterizationand device/performance insight (e.g. throat models prerecorded inhalation profiles) where applicable. Parenteral support: familiarity with peptide/oligonucleotide measurement science and control strategies.

• Experience supporting clinical manufacture and working with CMOs including method transferreadinessand comparability.

• Experience evaluating stability data and assigning shelf life to drug products usingappropriate statisticalmodels.

• Exposure to portfolios spanning multiple modalities and dosage formats (e.g. oral inhaled parenteral).

• Familiarity and interest inusingdata science tools including AI/ML and chemometrics to advance analytical interpretationrobustnesstuningand data flow.

• Consistent recordin analytical method lifecycle management and validation lifecycle of laboratory automation technologies underGxP.

• Practical experience with basic scripting in Python/R for data wranglingvisualizationand deployment of predictive models in an analytical context.

Why AstraZenecaAtAstraZenecawerededicated to being a Great Place to Workwhere you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.Theresno better place to make a difference in medicinepatientsand society. An inclusive culture that champions diversity and collaboration and a commitment to lifelong learninggrowthand development.

SoWhats Next Are you already imagining yourself joining our team Wecantwait to hear from you! Apply now.