СШАSenior Scientist I/Senior Scientist II, Analytical Sciences
3 нед. назад
СШАSenior
analytical method developmentoptimizationqualificationdata generation
Lead analytical method development and support eRNA and lipid nanoparticle programs in a biotech environment.
О компании
- is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail’s platform brings together programmable circular RNA technology (eRNA™), targeted nanoparticle delivery, and advanced computational approaches to design medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.
Обязанности
- is seeking a highly motivated and scientifically rigorous Senior Scientist to join the Analytical Sciences team. This individual will lead analytical method development, optimization, qualification, and transfer activities supporting Sail’s eRNA and lipid nanoparticle programs.
- The Senior Scientist will work at the interface of analytical development, process development, formulation, manufacturing, and product characterization. This individual will apply strong scientific judgment to solve complex analytical challenges, generate high-quality data, and develop phase-appropriate methods and testing strategies that support preclinical and clinical program advancement.
- The successful candidate is self-motivated, curious, collaborative, and comfortable operating in a dynamic, fast-paced environment. This role requires strong technical leadership, attention to detail, and a commitment to translating analytical insights into program decisions and meaningful impact for patients.
- Lead the development, optimization, qualification, and transfer of analytical methods for RNA drug substance, lipid nanoparticle drug product, process intermediates, raw materials, and in-process samples.
- Design and execute scientifically rigorous studies to characterize product quality, purity, potency, identity, concentration, and other critical quality attributes.
- Develop phase-appropriate analytical methods and define method performance criteria based on product knowledge, program stage, and intended use.
- Independently troubleshoot complex analytical and technical challenges and develop creative, data-driven solutions.
- Lead investigations of product- and process-related impurities, degradation pathways, method performance issues, and atypical analytical results.
- Collaborate cross-functionally with Process Development, Preclinical Manufacturing, MS&T, and platform teams to advance program goals.
- Evaluate and implement new analytical technologies that improve method robustness, sensitivity, throughput, scalability, or compliance.
- Author and review analytical procedures, protocols, technical reports, and study summaries.
- Maintain thorough and accurate documentation in electronic laboratory notebooks and relevant data management systems.
- Analyze and interpret complex datasets and present findings clearly in oral and written formats to internal and external stakeholders to enable alignment and decision-making.
- Manage multiple priorities, identify technical risks, and drive analytical deliverables to completion within program timelines.
- Stay current with relevant scientific literature, regulatory guidance, and technical advances in RNA therapeutics, nanoparticle delivery, and analytical development.
- Provide technical guidance and mentorship to junior scientists and contribute to a collaborative and accountable team environment.
Требования
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3+ years of relevant industry experience; M.S. with 7+ years of relevant industry experience; or B.S. with 9+ years of relevant industry experience.
- Demonstrated experience developing, optimizing, qualifying, validating, and transferring analytical methods in a biotechnology or pharmaceutical environment.
- Strong scientific background in analytical development for biologics, nucleic acid therapeutics, lipid nanoparticles, gene therapies, or other complex therapeutic modalities.
- Hands-on experience with multiple analytical techniques, such as chromatography, capillary electrophoresis, UV-Vis spectroscopy, dynamic light scattering, plate-based assays, ligand-binding assays, molecular biology methods, or cell-based assays.
- Demonstrated ability to independently design experiments, analyze complex data, troubleshoot technical problems, and drive studies to completion.
- Experience supporting product characterization, process development, formulation development, stability studies, specifications, or comparability assessments.
- Strong understanding of analytical method lifecycle principles, including development, qualification, validation, transfer, and performance monitoring.
- Excellent technical writing, data analysis, organizational, presentation, and communication skills.
- Demonstrated ability to manage multiple priorities while maintaining scientific rigor, attention to detail, and high-quality documentation.
- Strong collaborative spirit with the ability to work effectively across scientific disciplines and with internal and external partners.
Будет плюсом
- Experience with RNA analytical characterization, including methods for RNA identity, integrity, purity, concentration, structure, and functional expression.
- Experience with lipid nanoparticle characterization methods, such as particle size, polydispersity, encapsulation efficiency, lipid content, or potency.
- Experience supporting GLP toxicology, clinical manufacturing, stability, or regulatory submission activities, particularly experience with early Phase programs.
- Working knowledge of phase-appropriate GxP requirements and relevant ICH guidance.
- Experience working with CDMOs or contract testing laboratories.
- Experience with statistical analysis and information management tools such as JMP, GraphPad Prism, Benchling, or similar platforms.