Assoc. Princ. Scientist – Analytical Project Lead Pharmaceutical Development

What you will do

We are looking for you who combines a robust knowledge (or experience) in pharmaceutical development and strong analytical background with critical thinking to generate decisive data and control strategies. You are comfortable in aligning stakeholders, set direction and resolve ambiguity to keep programs on track and meet milestones. We see that you enjoy driving learning between projects and thrive in introducingnew technologiesand ways of working.

Responsibilities include, but will not be limited to:

• Project leadership: Act as analytical skillleadto secure major drug product deliveries, applying a risk based, flexible approach to prioritization and timelines.

• Analytical strategy & control: Define and own the analytical control strategy aligned with CH guidelines across clinical phases.

• Method development & validation: Design, develop,validateand transfer analytical methods (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, aerosol characterisation, including stabilityindicatingmethods) and specification setting.

• Characterisation & performance: Lead drug product characterization and stability programs.

• CMC & regulatory: Author/review analytical CMC content for IND/IMPD/NDA/MAA, as well as validation reports, method transfer documents, specifications, responses to regulatory queries and other CMC and regulatory documents.

• Cross functional collaboration: Work closely with formulators, device engineers, aerosol scientists, manufacturing sites and external partners/CMOs to integrate analytical deliverables into project plans.

• Technical supervision & coaching: Provide scientific,regulatoryand technical supervision; mentor and coach colleagues to enable projectobjectivesand build capability.

• Problem solving: Lead complex investigations, root causeanalysesand data integrity assessments; drivetimelyresolution and preventive actions.

• Ways of working & innovation: Enable learning between projects, and lead science/technology initiatives including patenting and/or publishing.

• Quality & governance: EnsureGxPcompliance where applicable, data integrity, rigorous studydesignand clear communication to governance bodies.

Essential requirements

• MSc or PhD or equivalent experience in a relevant scientific subject area (Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or related).

• Significant experiencein pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications.

• Proven record of leading teams and/or scientific projects within a global organization and with external partners.

• Extensive experience acting as project lead/skill lead and influencing cross functional strategies.

• Strongproficiencywith chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, aerosol characterization techniques used for inhaled product (such as impactor analysis) and complementary methodologies for small and/or large molecules.

• Experience in method development (including use of supporting software), validation, transfer and lifecycle management under ICH guidelines and phaseappropriate frameworks.

• Experience authoring CMC analytical content and responding to regulatory queries across clinical development.

• Excellent communication, stakeholder management and influencing skills

• Demonstrated ability to troubleshoot technical challenges and drive data driven decisions.

• Experience of advanced structured problem-solving techniques e.g. six sigma

• Fundamental digital and data capability relevant to analytical development, including proficiencywith multivariate experimental design and basic DoE concepts for method and process understanding; working knowledge of statistics for analytical science (e.g., regression, ANOVA, capability/variation analysis, stability trending, OOS/OOT investigation).

• Practical use of common data and workflow tools (e.g., ELN/CDS, and statistical software such as JMP or Minitab) for data analysis and reporting.

• Proficiencyin English, oral and written.

Desired requirements

• Experience working in GMP environments and corresponding instrument/equipment maintenance procedures.

• Knowledge of analytical development work and CMC deliveries across projects.

• Insight into device performance characterisation (e.g., throat models, prerecorded inhalation profiles) and sample preparation acrosspMDI/DPI/nebulisation.

• Experience with statistical analysis tools (e.g., Minitab) and DoE for method development, dataevaluationand acceptance criteria.

• For inhalation: advanced performance assessment techniques and aerosol characterisation; for oral products: solid-state characterisation (e.g., XRPD, DSC, TGA) and dissolution strategy.

• Experience supporting clinical manufacture and working with CMOs, including method transfer and comparability.

• Experience evaluating stability data and assigning shelf life to drug products.

• Experience applying advanced predictive analytics beyond foundational skills (e.g., Bayesian optimisation for robustness tuning, chemometrics for pattern recognition, mechanistic/hybrid models for dissolution or degradation kinetics, advanced statistical methods for specification setting and uncertainty quantification).

• Practical experience with data and workflow tools used in analytical development (e.g., ELN/CDS, statistical software such as JMP/Minitab, and basic scripting in Python/R for data wrangling, visualization, and predictive model deployment).