Scientist – Analytical Development, GPD

AstraZeneca • Durham, NC

12d • Onsite

About The Position

Are you an analytical scientist with extensive experience in routine analytical testing supporting development of new products? AstraZeneca’s Global Product Development (GPD) team is seeking a Scientist to expand analytical development capabilities especially with testing complex combination products within inhaled portfolio. 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 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 Scientist with a strong background and hands on experience with testing complex inhalation products, to drive AZ’s critical projects through development to commercialization. In this laboratory based and impactful role, you will support routine clinical lot releases, investigation work along with exposure to method development / optimization. You’ll work collaboratively across different functions to support key license to operate testing as well as complaint investigation. The role will be in Durham, North Carolina, USA, but is part of AZ’s Global Product Development organization with additional sites in Gothenburg, Sweden and Macclesfield, UK. GPD’s vision is to work 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 expert analytical support will range from early phase development work to late-stage cGMP testing. Experience with digital tools and AI is required to support 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 collaborative international team supporting various projects across different development lifecycles.

Requirements

• Bachelor’s degree with 3+ years experience, or Master’s with 0 or more years experience, in Chemistry, Pharmaceutical Sciences, or closely related field.
• Strong background in analytical methodologies for inhalation dosage forms
• Hands on experience working with HPLC/UPLC, moisture analyzer, and mass spectrometry is required.
• Proficiency with analytical software such as Empower, Tiamo, ELN is required.
• Hands-on proficiency with workflow optimization.
• Experience with statistical tools such as JMP is preferable.
• Excellent organizational, problem-solving, and collaborative communication skills.
• Experience working in a GMP/GxP regulated environment.
• Strong people, organizational, and communication skills (both written and oral)

Nice To Haves

• Exposure to analytical methodologies for portfolios that vary across modalities and/or dosage formats, including but not limited to oral solid and inhaled products.
• Familiarity or interest in utilizing data science tools, including AI / ML, to advance analytical interpretation and data flow.
• Experience collaborating in cross-functional global teams.

Responsibilities

• Manages own work to ensure that agreed targets are met in a timely manner and to agreed quality standards and communicating progress appropriately.
• Performs relevant experiments and interprets results based on a standard methodology in collaboration with formulation and/or device teams.
• Able to identify aberrant data and effectively communicate with project teams.
• Play a key role in supporting development work for automation to manual methods for inhalation products such as Delivered Dose Uniformity (DDU), aerodynamic particle size.
• Support technical and scientific review of data generated by peers.
• Identify and lead continuous improvement efforts to streamline laboratory operations and eliminate waste, ensuring compliance with GMP/GxP expectations.
• Champion laboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis.
• Demonstrate an active interest in leveraging AI /ML and other data science tools to enhance analytical results interpretation and workflow performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees