Opportunity Description
Our offer
Role summary
- Provide technical leadership within Manufacturing Science and Technology by defining and maintaining the processes as part of Tech transfer / NPI activities such as,
- ICH-Q3 risk assessments and testing strategies
- Establishment of an end‑to‑end process for materials management (raw materials, process consumables, single‑use components).
- Translate GMP and regulatory expectations into robust risk management strategies, ensuring compliance and reliable manufacturing & supply.
Your profile
Minimum qualifications, skills and competencies
- MS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field.
- 5+ years (Scientist/Engineer) in MSAT, Process Development, Quality, or related GMP manufacturing role in pharma/biotech.
- Hands‑on experience performing and defending drug product risk assessments (e.g. ICH Q3C and Q3D as...
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