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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.