Senior Scientist-Analytical Project Lead, Global Product Development

AstraZeneca•Durham, NC

1d•Hybrid

About The Position

Pharmaceutical Technology and Development (PT&D) within Operations is responsible for designing and delivering active ingredients, formulations, and devices for new medicines, as well as providing expert technical support for all AstraZeneca commercial drug substances and products. Within Global Product Development (GPD), the organization is seeking an experienced and innovative Analytical Project Lead based in Durham, North Carolina. This role focuses on transforming product design, development, and characterization to enable the delivery of new medicines to patients. The successful candidate will lead analytical strategy 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. The role involves acting as the analytical project/skill lead, partnering across formulation, engineering, biopharmaceutics, manufacturing, QA, and Regulatory to deliver robust methods, efficient control strategies, and submission-ready documentation. Additionally, the role will contribute to establishing and optimizing OSD laboratory capabilities at the Durham site, championing laboratory automation, and encouraging the adoption of modern data analytics and AI/ML tools to accelerate development and interpretation.

Requirements

Bachelor’s (12+ years), Master’s (6+ years), or PhD (or equivalent experience) in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or related field.
Significant experience in 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; additional experience with inhaled and/or parenteral products preferred.
Consistent record leading teams and/or scientific projects within a global organization and with external partners/CMOs; ability to influence cross functional strategies.
Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution and complementary methodologies; for inhaled products, familiarity with aerosol performance characterization is a plus.
Hands-on experience in method development (including use of supporting software), validation, transfer and lifecycle management under ICH guidelines and phase appropriate frameworks.
Experience authoring analytical CMC content for submissions and responding to regulatory queries across clinical development.
Experience working in a GMP/GxP environment; familiarity with instrument/equipment qualification, calibration and maintenance expectations.
Excellent communication, customer management and influencing skills; ability to operate confidently and collaboratively across global, cross-disciplinary environments.
Demonstrated ability to troubleshoot technical challenges and drive data driven decisions.
Fundamental digital and data capability relevant to analytical development, including: Proficiency with 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.

Nice To Haves

Strategic chromatographic and separation science leadership: define orthogonal method suites (e.g., RP, HILIC, ion exchange, SEC, SFC, CE) to secure impurity resolution and stability indicating capability; apply LC–MS(/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 establishing, equipping and optimizing OSD testing capabilities at the Durham site.
Experience with solid state characterization (e.g., XRPD, DSC, TGA) and dissolution strategy.
Inhaled support: advanced performance assessment techniques, aerosol characterization and 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 transfer, readiness and comparability.
Experience evaluating stability data and assigning shelf life to drug products using appropriate statistical models.
Exposure to portfolios spanning multiple modalities and dosage formats (e.g., oral, inhaled, parenteral).
Familiarity and interest in using data science tools, including AI/ML and chemometrics, to advance analytical interpretation, robustness tuning and data flow.
Consistent record in analytical method lifecycle management and validation lifecycle of laboratory automation technologies under GxP.
Practical experience with basic scripting in Python/R for data wrangling, visualization and deployment of predictive models in an analytical context.

Responsibilities

Act as analytical skill lead to secure major drug product deliveries, applying a risk based, flexible approach to prioritization, resources and timelines across modalities and dosage forms; integrate analytical plans with global teams and external partners/CMOs.
Define and own a phase appropriate analytical control strategy aligned with CMC expectations across clinical phases; harmonize methods and embed lifecycle management to ensure robust, efficient control.
Design, develop, validate, transfer and lifecycle manage analytical methods for OSD (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, stability indicating capability); establish scientifically supported system suitability, specifications and fit for purpose sample preparation; ensure readiness for GMP execution with clear documentation and analyst guidance.
Support inhaled and/or parenteral methods as needed.
Lead drug product characterization, comparability and stability programs; direct forced degradation studies; for inhaled products where required, support aerodynamic performance assessments (e.g., impactor analysis).
Author and review analytical CMC content for IND/IMPD/NDA/MAA; prepare validation reports, method transfer documents and specifications; lead responses to regulatory queries and support shelf life assignment with appropriate statistics.
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.
Champion laboratory automation for sample preparation, method execution and data analysis under GxP control.
Lead complex investigations, root cause analyses and data integrity assessments; apply structured problem solving (e.g., Six Sigma) and statistics to drive timely resolution and preventive actions.
Apply DoE and statistics for method robustness and understanding; use ELN/CDS and statistical tools; promote AI/ML, chemometrics and predictive analytics to enhance interpretation, specification setting and development speed; enable learning and standardization across projects; chip in to patenting and/or publishing.
Ensure GxP compliance where applicable, data integrity, rigorous study design and clear communication to governance bodies.

Benefits

An inclusive culture that champions diversity and collaboration, and a commitment to lifelong learning, growth and development.
A commitment to lifelong learning, growth and development for all.

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