Sr. Scientist

Job Description

Job Summary:

• We are seeking a highly motivated Scientist to join our Pharmaceutical Development team.
• This role will contribute to laboratory-based biologics drug product development by executing assigned studies and, as experience permits, planning and leading smaller defined work items under general to broad supervision.
• The role will support instrument setup and laboratory capability, phase-appropriate formulation and drug product process development, and physicochemical/bioanalytical characterization using state-of-the-art methods and equipment, including but not limited to UPLC or HPLC (SEC, RP, HIC, IEX/CEX, CAD preferred), charge variant analysis, particle analysis, CE-SDS, and other physical-property characterization.
• The successful candidate will collaborate with internal and external partners, communicate results and recommendations, and flexibly support multiple development projects in a fast-paced team environment.
• Experience with LC and iCiEF is required.

Duties and Responsibilities:

• Contribute to the setup, operation, maintenance, and routine troubleshooting of laboratory instruments; support method development and draft related procedures, reports, SOPs, and best-practice documentation.
• Independently execute assigned experiments and may plan or lead smaller, well-defined studies or work items supporting phase-appropriate formulation and drug product process development.
• Analyze and interpret experimental data, identify trends or atypical results, draw scientifically supported conclusions, and recommend next steps within defined project parameters; escalate complex issues as appropriate.
• Draft study plans, development reports, technical memos, and other scientific documentation with review from more experienced colleagues or management as appropriate.
• Collaborate with project management, quality assurance, analytical, R&D, non-clinical, manufacturing, and external partners to support development activities, technology transfer, and clinical material production.
• Communicate study progress, timelines, results, risks, and recommendations clearly to the manager and project team to support alignment and timely decision-making.
• Perform physicochemical and bioanalytical characterization using established analytical instrumentation and techniques and contribute to optimization of methods when needed.
• Prepare samples, solvents, standards, buffers, and other solutions with accurate calculations, weighing, documentation, and adherence to laboratory safety and Good Documentation Practices.
• Maintain laboratory notebooks, study documentation, inventory, and instrument maintenance schedules; contribute to laboratory organization and process improvements and may provide guidance to less-experienced colleagues on established procedures.
• Perform other duties as assigned.

Education:

• BS/BA or higher degree in Biotechnology, Biochemistry, pharmaceutical sciences, or a related field; an equivalent combination of education and relevant work experience may be considered.

Experience:

• BS/BA with approximately 4+ years of relevant experience or Master’s degree with approximately 2+ years of related experience.
• Relevant experience may include pharmaceutical formulation, process development, analytical development, or drug product development.
• Hands-on experience with state-of-the-art bioanalytical methods, including UPLC or HPLC (SEC, RP, HIC, IEX/CEX, CAD preferred), charge variant analysis, particle analysis, CE-SDS, and other physical-property characterization is preferred.
• Experience with LC and iCiEF is required.

Knowledge, Skills & Abilities:

• Working to strong understanding of the biochemical and physical properties of therapeutic biologics, including proteins and other relevant modalities, and of commonly used protein quantification and characterization approaches.
• Relevant experience with formulation, drug product, analytical, or related development activities for biologics; able to apply established scientific principles and procedures to assigned work.
• Hands-on experience with commonly used characterization and analytical instruments in a biologics drug product laboratory, with sufficient understanding of assay principles to independently perform routine work and troubleshoot minor instrument or method issues.
• Ability to analyze testing results, recognize trends and out-of-trend or atypical data, summarize findings, and make scientifically supported conclusions and recommendations within defined parameters.
• Strong technical writing skills with the ability to draft clear SOPs, study plans, best practices, technical reports, memos, and similar documentation.
• Ability to independently perform basic to moderately complex formulation and drug product studies and, with appropriate guidance, contribute to study design and optimization for biological drug candidates.
• Understanding of aseptic processing fundamentals and sterile fill-finish concepts for parenteral biological drug products.
• Working knowledge of GxP principles and compliance expectations for biological drug products is preferred.
• Strong organizational, analytical, and technical problem-solving skills; exercises sound judgment within established procedures and project objectives.
• Experience supporting pharmaceutical product development, process scale-up, technology transfer, or clinical manufacturing is preferred.
• Ability to prioritize assignments, manage multiple studies or work items, and meet deadlines with a high degree of accuracy and efficiency.
• Effective team player and collaborator who communicates clearly and timely with peers, managers, cross-functional partners, and external collaborators.
• Demonstrated Good Documentation Practices (GDP) and disciplined laboratory record keeping within a pharmaceutical or similarly regulated environment.
• Demonstrated growth in scientific knowledge, methods, and techniques, with willingness to learn new tools and apply feedback to increasingly complex assignments.
• Solid understanding of laboratory safety requirements and experience working safely in bioanalytical or pharmaceutical development laboratories.