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MacDonald Search Group is seeking a Senior Technical Services Scientist based in Montreal to lead transfer of processes from R&D to GMP manufacturing. You will oversee process validation projects and manage development documentation, including protocols, BOMs, and master batch records, ensuring knowledge transfer across teams.
You will drive continuous improvement, support risk management, and apply QbD and GMP principles to enhance product quality in a fast-paced pharma setting.
Based in Montreal
The Senior Technical Services Scientist plays a key role in supporting technical transfer and scale-up activities from R&D to GMP manufacturing. This position is responsible for leading process validation activities, managing scientific and technical documentation while ensuring the efficient transfer of knowledge and processes across teams and stakeholders. Responsibilities include documentation related to development studies, such as protocols, manufacturing instructions, bills of materials (BOMs), master batch records, and summary reports. The ideal candidate will contribute to continuous improvement initiatives, support risk mitigation efforts, and enhance product quality through a strong technical understanding of pharmaceutical manufacturing processes.
Le/La Scientifique principal(e), Services techniques joue un rôle clé dans le soutien des activités de transfert technologique et de mise à l’échelle entre la R&D et la production GMP. Ce poste est responsable de diriger les activités de validation des procédés, de gérer la documentation scientifique et technique, et d’assurer un transfert efficace des connaissances et des procédés entre les équipes et les parties prenantes. Les responsabilités comprennent la préparation de la documentation liée aux études de développement, notamment les protocoles, instructions de fabrication, nomenclatures (BOM), dossiers maîtres de fabrication et rapports sommaires. Le/la candidat(e) idéal(e) contribuera aux initiatives d’amélioration continue, soutiendra les efforts de gestion des risques et optimisera la qualité des produits grâce à une solide compréhension technique des procédés de fabrication pharmaceutique.