Lead tech transfer execution, organize the TT team, develop and manage the project plan with clear milestones, and drive risk and crisis management to ensure on-time, high‑quality transfer
Job Summary
Lead tech transfer execution, organize the TT team, develop and manage the project plan with clear milestones, and drive risk and crisis management to ensure on-time, high‑quality transfer.
Own process validation strategy and execution, including chromatography resin and reusable filter lifetime, mixing, cleaning, and yield studies.
Support compliance and regulatory activities, participate in GMP audits, on-site inspection, and regulatory filing as required.
Matching Summary
Lead tech transfer execution, organize the TT team, develop and manage the project plan with clear milestones, and drive risk and crisis management to ensure on-time, high‑quality transfer.
Skills & Requirements
Must-have
Tech transfer execution
Data integrity and compliance
Process validation strategy
Advanced data analytics
GMP audit support
Nice-to-have
Inclusive and diverse team
Industry-leading skills
Key Requirements
Master’s degree or above in biological or pharmaceutical discipline
More than 8 years’ experience in MSAT or process development
Proficient in QbD, GMP and other related regulations/guidance