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Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Loud Noises (Equipment/Machinery) Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Support the development deployment and lifecycle management of Process Analytical Technology (PAT) tools and multivariate models used in continuous manufacturing.
Apply chemometric techniques (e.g. PCA PLS) to develop validate and maintain predictive and/or classification models for process monitoring and control.
Analyze process and spectral data to support investigations trend analysis and performance supervising across product lifecycle stages.
Collaborate with operations quality engineering and analytical teams to ensure robust process control and monitoring.
Serve as the technical lead on client-facing projects and provide scientific justifications for model performance control strategies and data use.
Author protocols reports and documentation aligned with GMP and regulatory requirements.
Support the integration of process data infrastructure visualization and analytics tools (e.g. dashboards) into manufacturing workflows.
Provide day-to-day technical support for commercial CM processes and act as scientific owner for assigned products.
Bachelors degree in Chemical Engineering Pharmaceutical Sciences Chemistry Data Science or a related field is required. A Masters or Ph.D. with a focus on Chemometrics process systems engineering or data analytics is preferred.
Minimum of 5 years proven experience with a Bachelors degree
Minimum of 2 years with a Masters degree
No prior experience required with a Ph.D. if coursework and research align with Chemometrics continuous manufacturing or process modeling
Hands-on experience with continuous manufacturing PAT model development and spectroscopy techniques (e.g. NIR Raman)
Proficiency in programming language for data analysis modeling and visualization
Proven understanding of multivariate statistical analysis data preprocessing and validation methods
Familiarity with GMP FDA/EMA guidelines and ICH standards related to PAT and model validation
Experience with process control model monitoring or data integrity frameworks preferred
Excellent communication and problem-solving skills with the ability to lead multi-functional discussions
Organized dedicated and able to prioritize in a fast-paced environment
Position requires standard mobility and coordination to navigate office and manufacturing spaces; ability to stand walk kneel and occasionally lift items between 1035 pounds. Prolonged keyboard and screen use may be required.
Join Us
At Thermo Fisher Scientific your technical skills will directly support ground breaking continuous manufacturing initiatives. Help us drive innovation and deliver high-quality medicines faster and more efficiently.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate
Full-Time