Scientist Analytical Development

Scientist – Analytical Development, GPD

 

Job Description

• 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 Clients 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 Client’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.

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.
• Analyze release and stability samples for purity and activity for biologics.
• 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.

Minimum Qualifications: 

• Bachelor’s (3+ years), or Master’s (0+ years), in Chemistry, Pharmaceutical Sciences, or closely related field.
• Hands on experience with chromatographic separations.
• Experience working in a GMP/GxP regulated environment.
• Strong people, organizational, and communication skills (both written and oral).

Preferred Qualifications:

• Strong background in analytical methodologies with aerosol test methods (DD, NGI) for inhalation dosage forms
• Hands on experience working with HPLC/UPLC, SEC, IE, CE-SDS with a variety of detection techniques such as UV-Vis, Florescence, CAD for analysis of proteins and other large bio-molecules.
• Proficiency with analytical software such as Empower, Tiamo, and Electronic Lab Notebooks.
• Experience with statistical tools such as JMP is preferable.
• Excellent organizational, problem-solving, and collaborative communication skills.
• 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.

Physical Qualifications:

• Candidate should be able to stand to execute laboratory experiments at the bench.
• Candidate is expected to routinely be on-site with minimal remote work.