Intern, Pharmaceutical Engineering, Drug Product, PDM
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De functie
Serve as engineering support within the Drug Product team, collaborating with Scientists and Process Engineers to advance drug product manufacturing from clinical-stage to late-stage development and Process Performance Qualification (PPQ).
Support formulation and process development using Quality by Design (QbD) principles, including OFAT and DOE experiments.
Review protocols, manufacturing batch records, and development, campaign, and technical reports for readiness in scale-up and qualification.
Analyze data and perform statistical analyses to support process development, capability, and range justification.
Build and maintain databases to manage experimental data across multiple programs and conduct literature reviews to stay current with industry advances.
Communicate findings clearly to cross-functional teams and contribute to regulatory and manufacturing readiness for clinical and late-stage programs.
Support formulation and process development using Quality by Design (QbD) principles, including OFAT and DOE experiments.
Review protocols, manufacturing batch records, and development, campaign, and technical reports for readiness in scale-up and qualification.
Analyze data and perform statistical analyses to support process development, capability, and range justification.
Build and maintain databases to manage experimental data across multiple programs and conduct literature reviews to stay current with industry advances.
Communicate findings clearly to cross-functional teams and contribute to regulatory and manufacturing readiness for clinical and late-stage programs.
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