FSP – Scientist – Analytical Chromatography

Key Responsibilities

• Perform analytical testing of peptides, antibodies, antibody conjugates, and other biologic samples using established methods.
• Execute SEC/SEC-UV methods for assessment of monomer, aggregation, fragments, and lower-molecular-weight species.
• Execute RP-HPLC/UPLC methods for purity, related species, and degradation-product assessment.
• Execute IEX/CEX/AEX methods for charge and product heterogeneity assessment.
• Perform established CE-based methods, including CE-SDS/CGE and other assays as assigned.
• Support stability, formulation, comparability, and other characterization studies using established analytical methods.
• Plan and prioritize assigned sample testing to meet program needs and agreed timelines.
• Prepare samples, standards, controls, buffers, mobile phases, and other reagents according to established procedures.
• Operate HPLC/UPLC and CE instrumentation and ensure appropriate instrument readiness.
• Evaluate system suitability, controls, analytical performance, and data quality prior to reporting results.
• Process and review chromatographic and electrophoretic data using established integration, analysis, and reporting procedures.
• Recognize unexpected assay, instrument, column, or sample behavior; perform routine first-line troubleshooting; and escalate complex issues appropriately.
• Interpret and summarize analytical results and communicate relevant findings, data-quality concerns, technical risks, and potential delays to senior scientists and project teams.
• Maintain complete, accurate, and timely electronic laboratory notebook (ELN) entries and analytical records.
• Support routine instrument maintenance, column lifecycle management, consumable inventory, and laboratory organization.
• Provide guidance or training to less-experienced analysts on established methods and routine instrument operation, as appropriate.
• Collaborate with analytical scientists and cross-functional teams to ensure timely delivery of high-quality analytical data.

Education and Experience

Bachelor's degree in lab sciences such as Biochemistry, Pharmaceutical Sciences, Immunology, Biology, Molecular Biology or similar. 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.

Knowledge, Skills and Abilities

• Demonstrated hands-on experience with HPLC/UPLC and biologics sample analysis.
• Experience with SEC and RP-HPLC/UPLC required or strongly preferred.
• Experience with IEX/CEX/AEX and CE-SDS/CGE preferred.
• Familiarity with chromatography data systems such as OpenLab, Empower, Chromeleon, or equivalent.
• Experience working with peptides, proteins, antibodies, antibody conjugates, or other biologic modalities preferred.
• Strong hands-on laboratory skills with attention to detail and a commitment to reproducible, high-quality analytical work.
• Ability to independently execute established methods, review data quality, and assess system suitability.
• Ability to recognize and troubleshoot routine analytical or instrument issues and escalate complex problems appropriately.
• Sound scientific judgment and ability to interpret and clearly communicate analytical findings.
• Strong organization, prioritization, documentation, and time-management skills.
• Effective written and verbal communication skills with a collaborative, team-oriented approach.
• Responsible laboratory, instrument, and column stewardship.
• Ability to work effectively across multiple projects and biologic modalities while developing increasing analytical ownership.

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.