Senior Scientist – Analytical Lead

Overview

In this role you will lead analytical control strategies to accelerate medicines from lab to clinic. You’ll define end-to-end analytical strategies across development stages, collaborating with formulation, engineering, manufacturing, QA and Regulatory. You will leverage modern data analytics to shorten development cycles and ensure robust, compliant analyses for batch release. You’ll mentor colleagues, drive continuous improvement, and shape how data-driven decisions support regulatory success and commercial readiness. This is a hands-on, cross-functional leadership opportunity with a clear impact on patient outcomes.

Pay / Benefits

• on-site predominance
• flexible work options
• reasonable adjustments/accommodations
• opportunity to impact sustainability goals
• collaborative, supportive culture
• cutting-edge analytical technologies

Responsibilities

• Lead analytical strategy and risk-based prioritisation to meet major drug product delivery timelines
• Define end-to-end control strategy aligned with CMC guidelines across clinical phases
• Design, develop, validate and transfer analytical methods (HPLC/UPLC, LC–MS, dissolution, impurity profiling)
• Lead product characterisation and stability programmes to inform formulation choices and specifications
• Author analytical CMC content for IND/IMPD/NDA/MAA and respond to regulatory queries
• Embed analytical deliverables into project plans and enable tech transfer and scale-up
• Drive investigations, root cause analyses, and data integrity assessments with GxP compliance
• Apply multivariate design and DoE; promote ELN/CDS and statistical tools for decision making
• Deliver milestones, mentor colleagues, and contribute to continuous improvement in faster, sustainable medicine delivery

Key requirements

• MSc or PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or related
• Experience in pharmaceutical analytical science with regulatory CMC knowledge for clinical/marketing applications
• Proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and related methods
• Strong communication, stakeholder management and cross-functional collaboration skills
• Ability to troubleshoot technical challenges and drive data-driven decisions
• Fundamental digital/data capability including multivariate design and basic DoE concepts; experience with ELN/CDS and JMP or Minitab

• communication
• stakeholder management
• influencing
• HPLC/UPLC
• LC–MS
• dissolution testing

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