Scientist

Scientist, Analytical Development

Location: Durham, NC

Duration: 6 Months

Job Description

Are you an analytical scientist with extensive experience in routine analytical testing supporting development of new products? Companys Global Product Development (GPD) team is seeking a Scientist for 6 months to support testing complex combination products within inhaled portfolio and oral solid dosages.

At Company, 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 youre 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 COMPANYs 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. The role will be in Durham, North Carolina, USA, but is part of COMPANYs Global Product Development organization with additional sites in Gothenburg, Sweden and Macclesfield, UK.

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

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

Minimum Qualifications

• Bachelors (3 years), or Masters (1 years), in Chemistry, Pharmaceutical Sciences, or closely related field.
• Strong background in analytical methodologies for inhalation as well as oral dosage forms
• Hands-on experience working with HPLC/UPLC, moisture analyzer, and mass spectrometry is required.
• Proficiency with analytical software such as Empower and 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)
  
  

Preferred Qualifications

• 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.