Hands-on Tech Transfer/NPI specialist embedded in GMP operations, responsible for translating early-phase biologics (mAb) processes into executable GMP manufacturing documentation and digital systems. This role focuses on process implementation, digital alignment, and supporting a multi-product clinical biologics facility.
Project title: Operational Tech Transfer Specialist (m/f/d)
Type of employment: Payroll
Project start: 02.03.2026
Tasks:
Execute New Product Introduction (NPI) into GMP biologics manufacturing
Convert development process data into GMP-ready documentation (BOMs, batch records, EBR/gBMR, sampling plans)
Build and maintain digital manufacturing system data (MES, DeltaV, SAP COMET)
Perform risk assessments, change controls, and facility fit evaluations
Coordinate cross-functional tech transfer activities and timelines
Support digitalization and continuous improvement of tech transfer processes
Qualifications:
5+ years in GMP biologics drug substance manufacturing
Strong understanding of mAb upstream and downstream operations
Proven experience in Tech Transfer/NPI execution
Hands-on experience with MES, DeltaV, SAP, and GMP documentation authoring
Experience managing small cross-functional projects
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