Role Summary
Analytical Development Scientist to expand analytical capabilities for complex inhalation products within the AstraZeneca Global Product Development (GPD) organization. The role involves routine analytical testing, method development/optimization exposure, and collaboration across functions to support development through commercialization. Location: Durham, NC, USA.
Responsibilities
- Manages own work to ensure targets are met in a timely manner and to agreed quality standards, communicating progress appropriately.
- Performs relevant experiments and interprets results based on standard methodologies in collaboration with formulation and/or device teams.
- Able to identify aberrant data and effectively communicate with project teams.
- Support development work for automation to manual methods for inhalation products (e.g., Delivered Dose Uniformity, 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 GMP/GxP compliance.
- Champion laboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis.
- Demonstrate interest in leveraging AI/ML and other data science tools to enhance analytical results interpretation and workflow performance.
Qualifications
- Required: Bachelor’s degree with 3+ years of experience, or Master’s degree with 0+ years of experience, in Chemistry, Pharmaceutical Sciences, or closely related field.
- Required: Strong background in analytical methodologies for inhalation dosage forms.
- Required: Hands-on experience with HPLC/UPLC, moisture analyzer, and mass spectrometry.
- Required: Proficiency with analytical software such as Empower, TIA/TOI, ELN.
- Required: Hands-on proficiency with workflow optimization.
- Required: Experience with GMP/GxP regulated environment; excellent organizational, problem-solving, and collaborative communication skills.
- Preferred: Exposure to analytical methodologies for portfolios across modalities/dosage formats (including oral solid and inhaled products).
- Preferred: Familiarity with data science tools, including AI/ML, to advance analytical interpretation and data flow.
- Preferred: Experience collaborating in cross-functional global teams.
Skills
- Analytical problem-solving and data analytics
- Laboratory automation and process optimization
- Effective communication and collaboration
- Adaptability to cross-functional, global teams
- Interest in AI/ML and data science applications in analytics
Education
- Bachelor’s degree with 3+ years experience, or Master’s degree with 0+ years experience, in Chemistry, Pharmaceutical Sciences, or closely related field.