As Method Transfer QC Expert, you are the driving force behind smooth, compliant, and efficient assay transfers. You ensure every analytical method transferred to or from simAbs meets GMP expectations, customer requirements, and the specific analytical challenges associated with biosimilar development. You connect scientific insight with operational excellence and act as the technical link between simAbs, partners, and contract laboratories.
Responsibilities
* Plan, coordinate, and oversee analytical method transfers.
* Ensure GMP compliance and documentation accuracy at every step.
* Collaborate with internal teams, clients, and CROs to align on transfer scope and success criteria.
* Troubleshoot analytical issues, providing pragmatic and science-based solutions.
* Draft and review transfer protocols, qualification reports, and supporting documentation.
* Monitor assay performance post-transfer and propose continuous improvements.
* Support deviation handling and CAPA definition.
* Communicate progress, risks, and mitigation strategies to key stakeholders.
Vereisten
Qualifications
* Master's degree or PhD in Life Sciences, Biochemistry, or Biotechnology.
* Demonstrated experience in analytical method transfer for biopharmaceuticals in a GMP environment.
* Extensive knowledge of biosimilar analytics and hands-on experience with biosimilar method transfer, comparability assessments, or characterization studies (critical requirement).
* Good knowledge of regulatory requirements and QC principles.
Competences
* Strong analytical and troubleshooting skills.
* Project management mindset and ability to handle multiple priorities.
* Clear and confident communication with external partners.
* Collaborative, proactive, and quality-driven personality.
* Affinity with biotech start-up culture: fast-paced, dynamic, hands-on.