Position 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.
Essential Functions
" 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.
Common Knowledge & Skills
" 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.
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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.