As QC Method Transfer & Validation Expert at simAbs, you play a key role in transferring and validating analytical methods in a GMP environment. You ensure that methods are robust, compliant, and smoothly implemented — either internally or at external contract labs. You translate strategy into clear protocols, troubleshoot analytical challenges, and drive successful assay implementation.
Your responsibilities
* Lead, coordinate, and supervise analytical method transfers and validations (QC focus).
* Ensure GMP compliance and data integrity throughout transfer and validation activities.
* Collaborate closely with project teams, customers, and contract laboratories.
* Write, review, and approve protocols, reports, and technical documentation.
* Interpret analytical data and provide scientific oversight.
* Troubleshoot issues efficiently and propose corrective actions (CAPA).
* Monitor method performance and drive continuous improvement.
* Support process comparability assessments during product lifecycle changes.
1. MSc or PhD in Life Sciences (Biotechnology, Biochemistry, Bioengineering, or related).
2. Proven experience in QC method transfer and validation within biopharma or biotech.
3. Solid understanding of GMP and regulatory requirements.
4. Hands-on, analytical, and solution-oriented mindset.
5. Excellent communication and teamwork skills.