Senior Scientist

Senior Scientist –Analytical Development, GPD 

Location

• Durham, NC

Job Description

Are you an analytical scientist with robust method development experience for oral solid dosage forms and a passion for findinginnovativesolutions in pharmaceutical testing? AstraZeneca’s Global Product Development (GPD) team is seeking a Senior Scientistto enhance analytical development capabilities inthe growing oral solid portfolioand giveinnovative analytical approaches tothe existinginhaled portfolio.

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

Within Global Product Development, we are seeking an experienced and motivated Senior Scientist with a strong background in oral solid dosage forms, preferably with experience across multiple drug modalities, to drive AZ’s critical projects through development to commercialization. In this impactful role, you will drive analytical method development, validation, product characterization and investigational testing, cGMP testing support,technology implementation, and play a centralrole in establishing and optimizing laboratory capabilities for oral solid dosage analysis. You’ll work collaboratively across interdisciplinary global teams to drive projects forward and contribute to regulatory submission activities, while alsohelping motivateteamadoptionof emerging AI / ML tools that can enhance analytical data interpretation and workflow efficiency. The role will be located in Durham, North Carolina, USA, but is part of AZ’s Global Product Development organization with additionalsites in Gothenburg, Sweden and Macclesfield, UK.

GPD’s vision is towork in seamless ways that bring the best of our collective scientific capabilities to develop and deliver innovative and sustainable medicines, making a meaningful impact on patients’ quality of life.Within the role,your experienced analytical support will rangefrom early phase development work to late-stagecGMP testing andwill involve authoring regulatory submission documentsacross dosage form boundaries (e.g. oral and inhaled).

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 collaborative international team supporting various projects across different development lifecycles.

What you will do:

• Lead and perform analytical method development, validation, product characterization, and routine investigational and clinical release testing, working on inhaled andoral products, as needed.

• Play a key role in establishing, equipping, and optimizing laboratory setups for oral solid dosage (OSD) testing capabilities.

• Provide technical and strategic input on analytical issues relevant to OSD and, where required, across other modalitiesand/or dosage formats (e.g. inhaled, parenteral).

• Author and review analytical documentation to support regulatory submissions, ensuring compliance with GMP/GxP expectations including response to regulatory inquiries.

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

• Demonstrate an active interest in using AI /ML and other data science tools to enhance analytical results interpretation and workflow performance.

Minimum Qualifications:

• Bachelor’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a closely related field.

• Minimum of 8-10 years of experience with a Bachelors degree, or amaster's degree and a minimum of 4-6 years of experience.

• Strong background in analytical development fororal solid dosage forms. Preferred candidates will also have experience withtesting inhaled products.

• Demonstrated experience in method development, validation, and application in the pharmaceutical industry.

• Confirmed experience with regulatory submission processes and writing/reviewing analytical sections with response to regulatory inquiries.

• Hands-on proficiency with workflow optimization, experience with automation is preferred.

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

• Experience working in a GMP/GxP environment.

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

Preferred Qualifications:

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

• Familiarity or interest in applyingdata science tools, including AI / ML, to advance analytical interpretation and data flow.

• Experience collaborating in cross-functional global teams.

• Consistent track record in analytical method lifecycle management.

• Experience with validation life cycle management of laboratory automation technology to meet GxP requirements.

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your spirit. There’s no 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.

So What's Next

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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