Scientist, Analytical Development

Here's What You'll Do

• Design, develop, optimize, and execute separation-based analytical methods using LC/HPLC/UHPLC, LC-MS, capillary electrophoresis including CE-SDS, and other appropriate separation and detection technologies for early- and clinical-stage products.
• Develop fit-for-purpose methods to assess relevant product quality attributes, including purity, identity, product- and process-related impurities, degradation products, and other attributes requiring separation-based analytical resolution.
• Translate product and control-strategy needs into phase-appropriate method performance requirements, selecting appropriate separation modes, detection approaches, sample preparation strategies, and analytical controls for the intended use of the method.
• Systematically optimize critical method parameters including column or capillary chemistry, mobile-phase composition, gradient conditions, temperature, sample preparation, instrument settings, detection, data processing, and integration to achieve robust analytical performance.
• Apply risk-based development, structured experimentation, and Design of Experiments where appropriate to understand method robustness, identify critical sources of variability, and establish scientifically justified operating ranges and system-suitability controls.
• Troubleshoot complex separation challenges and investigate unexpected analytical observations by integrating chromatographic, electrophoretic, mass-spectrometric, and orthogonal data to develop scientifically sound hypotheses and solutions.
• Drive platform implementation by identifying opportunities to standardize and reuse analytical methods across related products and modalities, reduce unnecessary method proliferation, and establish scalable approaches that accelerate future program development.
• Partner closely with Analytical Product Leads (APLs), Analytical Sciences, Product Characterization, Process Development, and other CMC partners to connect separation-method development with product understanding, process-development needs, and evolving analytical control strategies.
• Collaborate with Analytical Technical Operations, Analytical Sciences & Technology (AST), and Quality Control to support method pre-qualification, technical transfer, qualification or validation, troubleshooting, and downstream implementation, designing methods from the outset with future routine use in mind.
• Evaluate and apply emerging separation and detection technologies such as advanced column chemistries, high-resolution and hyphenated LC-MS workflows, next-generation electrophoretic approaches, multidimensional or high-throughput separations, automated sample preparation, and advanced data-analysis tools when they provide meaningful scientific or operational value.
• Author and review analytical methods, protocols, development reports, technical summaries, and supporting documentation; maintain high-quality experimental records and communicate data, conclusions, risks, and recommendations clearly to technical and cross-functional stakeholders.

Here's What You'll Need (Basic Qualifications)

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 0-2 years of relevant experience; or M.S. with 8+ years; or B.S./B.A. with 10+ years of relevant industry experience.
• Strong hands-on experience with separation-based analytical methods, including liquid chromatography and at least one additional relevant platform such as LC-MS or capillary electrophoresis, is required.

Here's What You'll Bring to the Table (Preferred Qualifications)

• Strong scientific foundation in separation science, including chromatographic and electrophoretic principles, selectivity, resolution, mass transfer, sample chemistry, and the practical factors that drive method performance and robustness.
• Demonstrated hands-on experience developing and optimizing LC/HPLC/UHPLC methods; experience with multiple separation modes such as reversed-phase, ion-pair, ion-exchange, size-exclusion, or other application-relevant chromatographic approaches is highly desirable.
• Hands-on experience with capillary electrophoresis methods such as CE-SDS and/or related electrophoretic techniques, including method optimization, troubleshooting, and data interpretation.
• Experience with LC-MS or other hyphenated analytical technologies for method development, impurity identification, product characterization, or investigation support is strongly preferred.
• Experience supporting analytical development for mRNA, nucleic acids, lipid nanoparticles, proteins, conjugates, vaccines, biologics, or other advanced therapeutic modalities is preferred.
• Demonstrated ability to independently plan and execute method-development experiments, interpret complex analytical data, troubleshoot technical issues, and make data-driven recommendations within defined scientific objectives.
• Understanding of phase-appropriate analytical development and method lifecycle principles, including method development, robustness assessment, pre-qualification or qualification, technical transfer, validation, and continuous improvement.
• Familiarity with science- and risk-based analytical development principles, including ICH Q14/Q2 concepts, analytical target profile or intended-use thinking, Design of Experiments, and establishment of appropriate method controls and system-suitability criteria.
• Experience developing platform methods or implementing standardized analytical approaches across multiple products, programs, laboratories, or modalities is highly desirable.
• Experience with chromatography data systems such as Empower or Chromeleon, mass-spectrometry data systems, automated data processing, or laboratory automation is a plus.
• Strong scientific curiosity, written and verbal communication skills, and demonstrated ability to collaborate effectively across Analytical Development, Process Development, APL, AST, QC, and other multidisciplinary teams.
• Self-motivated and organized, with the ability to manage multiple experimental priorities while maintaining scientific rigor, data integrity, laboratory safety, and high-quality documentation, and a desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.