Sr. Scientist, Spectroscopy Lifecycle Support

1 giorno fa

Latina, Lazio, Italia Biopharma Careers Tempo pieno

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Job Function

R&D Product Development

Job Sub Function

R&D Digital

Job Category

Scientific/Technology

All Job Posting Locations

Latina, Italy

Job Description

We are seeking a Sr. Scientist in Spectroscopy and PAT Model Lifecycle Support to join ANVIL, the ApplicatioNs, Validation, Integration, and Lifecycle group within the Process Science Modelling and Data (PSMD) organization in Manufacturing Science and Technology (MSAT). ANVIL supports the development, validation, deployment, integration, troubleshooting, and lifecycle maintenance of models used to support manufacturing, including models deployed or intended for use in GMP environments.

This role will focus on spectroscopic Process Analytical Technology models, with particular emphasis on near-infrared spectroscopy and Raman spectroscopy. The successful candidate will help sustain and develop chemometric models that support product and process understanding, real-time or near-real-time decision making, and reliable operation of model-enabled workflows across manufacturing and laboratory environments.

The ideal candidate will bring hands‑on experience with spectroscopy, multivariate modeling, and data analysis, along with a practical interest in applying these skills in regulated pharmaceutical manufacturing. The candidate should be comfortable working across scientific, technical, quality, and operational boundaries, translating complex model behavior into clear decisions, documentation, and recommendations.

Key Responsibilities

Validation, Deployment, and GMP Lifecycle Support

  • Support validation and implementation of chemometric models used in GMP or GMP‑adjacent environments.
  • Use sound statistical reasoning to assess model performance, residuals, prediction error, bias, variance, outliers, and sources of model drift.
  • Contribute to model validation protocols, validation reports, technical transfer packages, model maintenance plans, and lifecycle documentation.
  • Troubleshoot deployed models, including investigation of spectral quality issues, unexpected predictions, drift, transfer challenges, and model or workflow failures.
  • Support deployment of models into operational workflows, including collaboration with platform, laboratory, manufacturing, quality, IT, and automation partners.
  • Help ensure model lifecycle activities are documented, traceable, and aligned with intended use, regulatory expectations, and internal quality procedures.
  • Contribute to best practices for spectroscopic model development, validation, maintenance, troubleshooting, and lifecycle management.

Chemometric Model Development and Evaluation

  • Develop, evaluate, and document chemometric models for spectroscopic PAT applications, including NIR, Raman, or related spectroscopic modalities.
  • Apply multivariate data analysis methods such as Principal Component Analysis, Partial Least Squares regression, classification approaches.
  • Utilize statistics to develop thresholds on key model outputs.

Other Tasks

  • Learn and apply Python‑based workflows for data analysis, model development, model evaluation, visualization, and automation.
  • Use git or similar version control practices to support traceability, collaboration, and maintainable scientific code.
  • Develop reusable analysis patterns, scripts, notebooks, and templates that improve consistency and efficiency across model development and lifecycle activities.

Required Qualifications

  • Degree or higher in Chemistry, Chemical Engineering, or a related scientific or technical discipline. BS with 4+ years experience
  • MS with 2+ years experience
  • PhD, experience preferred
  • Deep expertise with spectroscopy in at least one field or modality, such as NIR, Raman, MIR, UV-Vis, fluorescence, or related field.
  • Experience developing, evaluating, or applying models to scientific, analytical, process, manufacturing, or laboratory data.
  • Statistical fluency, i