Research Associate

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

• Are you an analytical scientist with extensive experience in analytical testing supporting development of new products? Client'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 client, 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.

• 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.

• 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).

• 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.

• 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.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.