Associate Scientist, Analytical Chemistry

About the role

As an Associate Scientist in Analytical Chemistry at our Durham facility, you will perform analysis of drug substance and drug product for potential ophthalmic medicines. Your work will support the development and validation of analytical methods, ensuring compliance with cGMP, safety, and regulatory requirements.

Responsibilities

• Perform analysis of drug substance and drug product, including sample analysis, release, stability, structural analysis, and IPC analysis of starting materials, intermediates, drug substance, and drug product materials.
• Analyze and evaluate materials and products at all stages of the pharmaceutical product development process.
• Generate analytical data for new and existing methods to troubleshoot issues.
• Develop and validate analytical methodology, including stability-indicating HPLC methods, GC methods, and Karl Fischer for new drug substances and products.
• Perform and verify compendial methods.
• Assist in the design and execution of clinical phase-appropriate method validation and stability protocols.
• Execute stability studies to support the development of new drug substances or drug products.
• Compile laboratory data and assist in laboratory investigations for aberrant and out-of-specification data.
• Author technical documents such as method development/validation reports, stability reports, and certificates of analysis with assistance.
• Maintain laboratory records and provide peer review of laboratory data.
• Schedule work activities with supervision and maintain laboratory supplies and equipment.
• Author and/or review standard operating procedures pertaining to analytical testing and reporting.
• Execute investigational studies in collaboration with others to address specific issues.
• Assist in authoring regulatory documents.
• Monitor and evaluate completion of tasks and projects.
• May assist in budget preparation for laboratory equipment.

Requirements

• Bachelor’s Degree or equivalent years of directly related experience (or high school diploma + 8 years; Associate’s degree + 4 years).
• Ability to fluently read, write, understand, and communicate in English.

Preferred Qualifications

• BS/BA in Chemistry or related discipline with at least 5-8 years of relevant experience.
• Strong laboratory skills in analytical testing for small molecules.
• Experience with HPLC/UPLC, GC, GC with headspace, Karl Fischer, FT-IR, and other physical testing including pH, HIAC, and viscosity.
• Comfortable working in a fast-paced environment with the ability to rapidly flex activities and priorities.
• Goal-oriented with excellent communication (written and oral) and organizational skills.
• Ability to work effectively in teams.
• Experience with Empower software and electronic notebook (ELN) preferred.
• Experience with analysis and/or analytical development for sterile solutions is preferred.

Benefits

• Robust benefits package including health, life, retirement, and flexible time off.
• Focused growth and development opportunities.
• Collaborative environment with opportunities to share processes and findings.