Technology Transfer Project Manager
OverviewIn this role you lead technology transfer and industrialization efforts for small molecule products, ensuring robust technical oversight across internal and external manufacturing sites. You will coordinate cross-functional teams to drive project execution, manage risks, and support supply continuity. You help shape scalable processes and maintain regulatory and GMP alignment in a fast-paced environment. This position offers impact across commercialization, lifecycle management, and continuous improvement within a global pharma setting.
Responsabilità
Lead technology transfer projects for small molecule drug products across internal and external manufacturing sitesCoordinate TT master plans, protocols, gap assessments, process descriptions, validation strategiesSupport process scale-up, PPQ, and readiness of manufacturing documentationTroubleshoot technical issues, propose solutions, and guide SME/CDMO decision-makingEnsure alignment with CMC, regulatory commitments, and change control processesProvide technical oversight for commercial processes across solid dosage, semisolid, sterile and non-sterile formsReview and approve manufacturing documentation (batch records, SOPs, control strategies)Analyze manufacturing data, identify optimization opportunitiesSupport process validation, OOS/OOT investigations, deviation resolution,
and CAPA definitionDrive cross-functional teams to ensure timely delivery of project milestonesCoordinate information flow with internal and external stakeholders for transparencyManage timelines, budget, risks, mitigation plans, KPIs, and governance reportingFoster collaboration across functions and geographies while maintaining GMP/regulatory awareness
Requisiti fondamentali
Min. 6-7 years’ experience in MSAT, Technical Operations, Technology Transfer in pharmaSolid understanding of manufacturing processes for solid oral dosage forms, semisolids, and sterile/non-sterile liquidsExperience managing technology transfer, process validation, and commercial manufacturing supportCompetence in reviewing technical documentation and scientific/quality evaluationsStrong knowledge of ICH guidelines, GMP, validation principles, and change controlAbility to work under pressure, manage multiple priorities, and operate in cross-functional settingsExperience with external manufacturing management (CMOs/CDMOs) is a strong plusQC/QA or CMC background considered a significant advantageStrong analytical mindsetProblem-solving and autonomous decision-makingAbility to work with global teams and adapt to different culturesMSAT and technology transfer leadershipProcess validation and PPQGMP compliance and regulatory frameworks
Responsabilità
Lead technology transfer projects for small molecule drug products across internal and external manufacturing sitesCoordinate TT master plans, protocols, gap assessments, process descriptions, validation strategiesSupport process scale-up, PPQ, and readiness of manufacturing documentationTroubleshoot technical issues, propose solutions, and guide SME/CDMO decision-makingEnsure alignment with CMC, regulatory commitments, and change control processesProvide technical oversight for commercial processes across solid dosage, semisolid, sterile and non-sterile formsReview and approve manufacturing documentation (batch records, SOPs, control strategies)Analyze manufacturing data, identify optimization opportunitiesSupport process validation, OOS/OOT investigations, deviation resolution,
and CAPA definitionDrive cross-functional teams to ensure timely delivery of project milestonesCoordinate information flow with internal and external stakeholders for transparencyManage timelines, budget, risks, mitigation plans, KPIs, and governance reportingFoster collaboration across functions and geographies while maintaining GMP/regulatory awareness
Requisiti fondamentali
Min. 6-7 years’ experience in MSAT, Technical Operations, Technology Transfer in pharmaSolid understanding of manufacturing processes for solid oral dosage forms, semisolids, and sterile/non-sterile liquidsExperience managing technology transfer, process validation, and commercial manufacturing supportCompetence in reviewing technical documentation and scientific/quality evaluationsStrong knowledge of ICH guidelines, GMP, validation principles, and change controlAbility to work under pressure, manage multiple priorities, and operate in cross-functional settingsExperience with external manufacturing management (CMOs/CDMOs) is a strong plusQC/QA or CMC background considered a significant advantageStrong analytical mindsetProblem-solving and autonomous decision-makingAbility to work with global teams and adapt to different culturesMSAT and technology transfer leadershipProcess validation and PPQGMP compliance and regulatory frameworks