FSP - Scientist - Drug Product Analytical

Key Responsibilities

• Collaborate closely with Pharmaceutical Development, Analytical Development, Research/Discovery.
• Design and execute analytical testing to support preformulation, formulation screening and optimization, process development, container-closure compatibility, in-use studies, and phase-appropriate parenteral drug product development.
• Plan and execute scientifically rigorous studies, including stability and stress studies, to understand the impact of formulation composition and process parameters on drug product critical quality attributes.
• Perform routine and non-routine analytical testing of formulation and process-development samples, including assay/purity and degradation-product analysis by reversed-phase HPLC and aggregate/fragment analysis by size-exclusion chromatography (SEC).
• Execute, optimize, and troubleshoot fit-for-purpose analytical methods used to support formulation, stability, and process-development studies.
• Support laboratory investigations and troubleshooting of unexpected analytical results, method performance issues, and drug product stability or process-related observations.
• Operate, troubleshoot, and maintain HPLC/UPLC instrumentation and associated chromatography data systems; contribute to evaluation and implementation of analytical technologies needed to support parenteral drug product development.
• Prepare, review, and maintain laboratory notebooks, test methods, protocols, reports, data summaries, and other pharmaceutical development documentation with a high standard of scientific integrity and data quality.
• Analyze and trend analytical data, clearly communicate conclusions and limitations, and connect analytical results to formulation and process-development decisions.
• Manage laboratory organization, ordering consumables, and coordinating future lab buildout as necessary.
• May train colleagues on analytical methods, instrumentation, and laboratory procedures as appropriate.
• Perform other duties as assigned.

Education and Experience

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR Masters degree. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Demonstrates ability to work independently or as part of a team.
• Consistently identifies anomalous or inconsistent data, determines root cause, and implements scientifically sound solutions with minimal oversight.
• Demonstrates deep practical expertise in chromatographic analysis and applies analytical science to solve complex formulation, stability, and process-development problems.
• Strong command of scientific principles, methods, and techniques, with ability to translate theory into practical development solutions.
• Demonstrated proficiency with HPLC/UPLC systems and chromatography data analysis; able to troubleshoot chromatographic, instrument, sample-preparation, and method-performance issues independently.
• Strong analytical thinking and creative problem-solving skills in a cross-functional, matrix environment.
• Excellent written and verbal communication skills, including preparation of technical reports and delivery of scientific presentations to internal and external stakeholders.
• Detail-oriented while maintaining awareness of broader scientific, regulatory, and commercial implications.
• Demonstrates accountability for own work and project outcomes.

Job-Specific Knowledge & Qualifications

• Strong understanding of analytical laboratory practices, data integrity, and phase-appropriate GxP expectations supporting pharmaceutical development.
• Extensive hands-on HPLC experience is required, including reversed-phase chromatography for assay, purity, and degradation-product analysis and size-exclusion chromatography (SEC) for aggregate and/or fragment analysis.
• Hands-on experience supporting formulation, stability, or process-development studies for parenteral drug products is preferred.
• Experience interpreting chromatographic data and using analytical results to assess formulation and process effects, degradation pathways, product stability, and critical quality attributes.
• Experience with ion-exchange chromatography (IEX) is preferred but not required.
• Familiarity with complementary parenteral drug product characterization techniques such as pH, osmolality, SoloVPE, particulates (HIAC & MFI), cIEF, ceSDS, or other physicochemical methods is a plus.
• Experience generating, reviewing, and summarizing analytical data for development reports, stability programs, investigations, and CMC documentation is preferred.
• Working knowledge of ICH and regulatory expectations relevant to analytical testing, stability, and parenteral drug product development is a plus.
• Ability to prioritize work under tight timelines.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.