Analytical Development Principal Scientist

Analytical Development Principal Scientist

Esteve CDMO

Department: Analytical Development

Reports to: Manager Analytical Development

Employment Type: Full-Time, Exempt

Position Summary

An Analytical Development Principal Scientist will serve as a technical subject matter expert (SME) in analytical method development, validation, and troubleshooting. This role is both a hands-on scientific laboratory position and a client-facing role and will act as the primary technical liaison between the lab, internal departments, and client organizations across the product lifecycle, from early phase through commercial manufacturing. As a member of a project Core Team, the incumbent will assume ownership of required analytical development activities to support relevant projects with minimal supervision and will respond to all stakeholder inquiries regarding progress and technical troubleshooting. The incumbent will likely provide supplemental support to multiple projects while having 1-2 projects with primary responsibility. The incumbent will have responsibility for instrumentation maintenance and management as well as offering mentorship and training to junior analytical development chemists.

Key Responsibilities

Technical and Scientific Leadership

• Design, develop, optimize, and validate analytical methods (HPLC/UPLC, LC/MS, GC, GC/MS, HRMS, ICP/MS, titration/wet chemistry, UV, IR, Karl Fischer, PSD, DSC, TGA, DVS, XRPD, NMR and related techniques) for drug substance assessment.
• Participate in root cause analysis as requested.
• Write, and review test method protocols/reports, stability protocols, specifications, and analytical risk assessments as needed.
• Provide technical oversight for analytical method transfers between labs or to and from various client sites.
• Maintain current expertise in regulatory guidance and ensure all methods and practices remain compliant.
• Maintain scientific curiosity and continuous learning by keeping current with relevant advances in analytical chemistry through conferencing, technical discussions and reviewing relevant scientific literature.
• Ensure appropriate scientific consistency is applied throughout the department by setting an example of maintaining the highest standards of scientific rigor.
• Mentor and train junior and mid-level scientists; review their work and provide technical guidance.
• Support continuous improvement initiatives, including evaluation of new instrumentation and analytical technologies.

Client-Facing Responsibilities

• Participate as a Core Team Member by acting as the primary technical point of contact for client teleconferences, technical reviews, and on-site visits.
• Present analytical strategies, data packages, and scientific rationale directly to client scientists and relevant stakeholders.
• Provide input to client expectations around analytical risk, timelines, and method strategy; communicate issues proactively and propose solutions.

Internal Stakeholder Collaboration

• Partner closely with Process Chemistry team to provide proactive analytical troubleshooting and provide relevant input on specifications and control strategy.
• Work closely with Quality Control team to ensure smooth transfer of test method protocols for validation.
• Provide timely contributions and response to Project Management to align on project timelines and technical decisions.
• Serve as SME during client audits.

Compliance and Documentation

• Ensure all laboratory work is performed in compliance with current Good Documentation Practice (GDP) and data integrity policies.
• Author and review SOPs (Standard Operating Procedures), technical reports, protocols, and investigation summaries as needed.
• Maintain accurate, audit-ready documentation in accordance with data integrity requirements.

Required Qualifications

• B.S., M.S., or Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field, with corresponding industry experience (e.g., Ph.D. plus 3 years, M.S. plus 7 years, or B.S. plus 10 years in pharmaceutical analytical development).
• Extensive hands-on expertise with HPLC/UPLC, GC, and wet chemistry techniques; expertise with spectroscopic methods (UV-Vis, IR, NMR, XRPD); mass spectrometry experience a plus.
• Strong working knowledge of ICH Q2(R1) method validation, ICH Q1 stability guidelines, USP/EP/JP compendial methods, and FDA/EMA regulatory expectations.
• Demonstrated experience developing and validating methods across multiple phases, from preclinical through commercial.
• Prior experience in a client-facing technical lead role within a CDMO, CRO, or pharmaceutical manufacturing environment.
• Excellent written and verbal communication skills, including experience presenting technical data to external stakeholders.

Preferred Qualifications

• Proficiency with chromatography data systems (e.g., Empower, Chromeleon) and LIMS (Laboratory Information Management System) platforms.
• Broad experience with analytical techniques to include solid state or material characterization such as DSC, TGA, DVS, PSD, XRPD, etc.
• Experience with technology transfer between development and commercial manufacturing sites.
• Prior experience in a project-lead role.
• Experience with complex analytical modalities such as derivatization methods and other complex analyte assessment.

Core Competencies

• Strong analytical and critical-thinking skills with a track record of effective troubleshooting.
• Ability to build trust and credibility with client stakeholders at multiple levels, from bench scientist to quality leadership.
• Comfortable managing multiple concurrent client projects and competing deadlines.
• Demonstrated mentorship and informal leadership ability.

Work Environment

• Combination of laboratory and office-based work.