QCAD Specialist II – GMP Analytical Development
Packgene-Biotech
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Résumé du poste
PackGene Biotech, headquartered in Houston, seeks a QCAD Specialist to join the Quality team. The role involves GMP‑compliant lab work across molecular, cellular, and biochemical assays, with emphasis on qPCR/ddPCR, ELISA, and cell culture.
You will support method development, validation, and routine GMP testing under senior guidance. The successful candidate will have a Bachelor's (and/or MS) in biological sciences and hands-on GMP experience, plus strong data integrity and documentation
Qualifications
- Bachelor's degree in biological sciences or related field required.
- Hands-on experience with molecular biology and GMP environments preferred.
- Experience with analytical method development and validation is a plus.
Responsabilités
- Perform GMP-compliant laboratory testing according to approved procedures.
- Operate qPCR, ddPCR, ELISA and other analytical instruments per SOPs.
- Support method development, qualification/validation and transfers.
- Draft and revise SOPs, protocols and study reports with proper documentation.
- Maintain sample inventory, prepare reagents, and track equipment maintenance.
- Collaborate with cross-functional teams to meet development timelines.
Connaissances
Formation
Outils
Description du poste
PackGene Biotech, headquartered in Houston, seeks a QCAD Specialist to join the Quality team. The role involves GMP‑compliant lab work across molecular, cellular, and biochemical assays, with emphasis on qPCR/ddPCR, ELISA, and cell culture.
You will support method development, validation, and routine GMP testing under senior guidance. The successful candidate will have a Bachelor's (and/or MS) in biological sciences and hands-on GMP experience, plus strong data integrity and documentation
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