Senior / Principal Scientist - QC Analytical SME

We are seeking a Senior / Principal Scientist - Quality Control Analytical SME with deep expertise in solid‑state and non‑chromatographic analytical technologies to provide scientific and compliance leadership within a commercial QC laboratory environment.

This is a senior individual‑contributor role for an experienced analytical professional who acts as a technical authority and subject‑matter expert (SME) across non‑chromatographic QC laboratories. The position plays a critical role in shaping analytical standards, ensuring inspection readiness, and driving continuous improvement aligned with evolving regulatory expectations and industry best practices.

The role is ideally suited for a highly experienced QC or CMC analytical scientist who operates comfortably at the interface of QC, QA, manufacturing, MSAT, R&D, and regulatory functions, and who is recognised as a technical reference by laboratory staff and management alike.

Key Responsibilities

Technical & Scientific Leadership

• Act as SME and technical authority for solid‑state and non‑chromatographic analytical techniques in a GMP QC environment.
• Provide scientific oversight and coaching to laboratory personnel on complex analytical and technical topics.
• Serve as escalation point for complex scientific, quality, and compliance issues related to assigned analytical technologies.

Quality & Compliance

• Independently prepare, review, and approve GMP procedures, standards, and guidance documents applicable to non‑chromatographic QC laboratories.
• Lead and support complex investigations, including root cause analysis and CAPA development.
• Ensure laboratories remain inspection‑ready and act as a technical spokesperson during regulatory inspections.
• Promote continuous adherence to GMP, data integrity, and quality culture.

Analytical Excellence & Lifecycle Management

• Drive systematic improvements in non‑chromatographic analytical practices through change controls and structured implementation plans.
• Lead analytical lifecycle management activities, including method validation, method transfer, and compendial method implementation.
• Support the introduction and qualification of new analytical technologies and equipment.
• Act as system owner for an extensive portfolio of laboratory instruments, ensuring training and access controls are maintained.

Cross‑Functional & Global Engagement

• Maintain close collaboration with QC supervisors, QA, manufacturing, R&D, MSAT, and regulatory partners.
• Participate in local and global working groups focused on analytical innovation, PAT, RTRT, and best‑practice implementation.
• Monitor regulatory and compendial changes (e.g., Ph. Eur., USP, JP, BP, ChP, IP) and ensure fit‑for‑purpose local implementation.

Required Qualifications

Education

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline (PhD preferred).

Experience

• Minimum 5+ years experience in the small‑molecule CMC analytical space (QC, Analytical R&D, MSAT, or industrialization).
• Experience supporting late‑stage development and/or commercial API manufacturing.
• Strong working knowledge of:
  • Analytical method validation, transfer, and verification
  • Stability and release testing
  • Compendial requirements and implementation

Technical Expertise

• In‑depth experience with non‑chromatographic analytical techniques, including:
  • Solid‑state characterization (e.g. XRPD, particle size by laser diffraction)
  • Titrations (KF, potentiometric)
  • IR, UV, Raman spectroscopy
  • Elemental analysis (AAS, ICP‑OES/MS)
• Understanding of QbD, lifecycle management, and risk‑based control strategies.
• Familiarity with PAT, RTRT, chemometrics, and multivariate modelling is advantageous.

Regulatory Knowledge

• Strong understanding of cGMP and analytical regulatory frameworks, including:
  • ICH Q1, Q2, Q3 (A/C/D), Q6, Q7, Q8-Q12, Q14, M7
  • Current expectations around impurity and nitrosamine management

Key Competencies

• Recognised as a technical expert and influencer rather than a line manager.
• Excellent stakeholder engagement, communication, and negotiation skills.
• Ability to work independently in a complex, matrixed environment.
• Full professional proficiency in English; working knowledge of Dutch is an advantage.