We are seeking an experienced and innovative Analytical Project Lead (Associate Principal Scientist) in global product development (GPD). In this role, you will lead analytical strategy and delivery for oral solid dosage forms and/or inhaled products from early development through clinical supply and toward commercialization.
Acting as a project lead/skill lead for analytical, you will partner across formulation, device engineering, biopharmaceutics, manufacturing, QA and Regulatory to deliver robust methods, efficient control strategies, and regulatory submission ready documentation.
The role
We are looking for you who combines a robust knowledge 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 introducing new technologies and ways of working.
Responsibilities include, but will not be limited to:
* Act as analytical skill lead to secure major drug product deliveries, applying a risk based, flexible approach to prioritization and timelines.
* Define and own the analytical control strategy aligned with CH guidelines across clinical phases.
* Design, develop, validate and transfer analytical methods (e.g., HPLC/UPLC, LC-MS, dissolution, impurity profiling, aerosol characterisation, including stability indicating methods) and specification setting.
* Lead drug product characterization and stability programs.
* 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.
* Work closely with formulators, device engineers, aerosol scientists, manufacturing sites and external partners/CMOs to integrate analytical deliverables into project plans.
* Provide scientific, regulatory and technical supervision; mentor and coach colleagues to enable project objectives and build capability.
* Lead complex investigations, root cause analyses and data integrity assessments; drive timely resolution and preventive actions.
* Enable learning between projects, and lead science/technology initiatives including patenting and/or publishing.
* Ensure GxP compliance where applicable, data integrity, rigorous study design and 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 experience in 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.
* Strong proficiency with 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 phase appropriate 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 proficiency with 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.
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 across pMDI/DPI/nebulisation.
* Experience with statistical analysis tools (e.g., Minitab) and DoE for method development, data evaluation and 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).
We work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. We welcome your application no later than 16th March 2026!
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