Senior Scientist - SEC / iCIEF / Impurity

Key Responsibilities

• Support technical transfer, implementation, validation, remediation, and lifecycle activities for biologics separation methods, including LC, SEC, P188, icIEF, CE-SDS, peptide mapping and impurity assays.
• Independently author, review, and approve technical protocols and reports, technical assessments, procedures, and related lifecycle documentation.
• Develop transfer study designs, testing plans, acceptance criteria, and data-evaluation approaches based on method performance, product knowledge, and receiving-laboratory capabilities.
• Manage planning and shipment of critical analytical reagents and materials, including reference standards, system suitability controls, columns, kits, and method-specific reagents.
• Support laboratory investigations, deviations, CAPAs, OOS/OOT assessments, change controls, impact assessments, risk assessments, and method performance trending.
• Provide accurate analytical content and source document support for regulatory submissions, health authority responses, inspection readiness, and lifecycle commitments.

Education and Experience

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar. Sr. Scientist: Previous experience comparable to 4+ years, OR Masters degree with comparable 2+ years, OR PhD. Equivalency of education, training and/or directly related experience may be considered.

Knowledge, Skills and Abilities

• Strong practical experience in analytical method development, validation, transfer, lifecycle management, and troubleshooting for biologics and/or cell and gene therapy products.
• Working expertise with analytical technologies such as HPLC/UPLC, capillary electrophoresis, icIEF, SEC, peptide mapping, protein concentration methods including SoloVPE, and impurity methods.
• Solid knowledge of current Good Manufacturing Practice requirements and analytical expectations under ICH, USP, Ph. Eur., JP, and applicable FDA guidance.
• Experience with analytical data review, trending, comparability assessment, and statistical tools such as JMP is preferred.
• Familiarity with reference material qualification, stability and requalification, inventory management, and method specific system configuration is preferred.
• Experience working within quality systems and electronic document platforms supporting change control, deviations, CAPA, controlled procedures, and technical records.
• Strong technical writing, communication, collaboration, and influencing skills, with the ability to work effectively in a matrixed environment.
• Ability to operate independently on defined workstreams, recognize when escalation is needed, and balance scientific rigor, compliance, timeline, and business risk.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people.
• 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.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.