QC Method Transfer

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.

• MSc or PhD in Life Sciences (Biotechnology, Biochemistry, Bioengineering, or related).

• Proven experience in QC method transfer and validation within biopharma or biotech.

• Solid understanding of GMP and regulatory requirements.

• Hands-on, analytical, and solution-oriented mindset.

• Excellent communication and teamwork skills.