Job Description:
 

• Assist the QC Manager in organizing and monitoring overall activities and coordination in QC Department.

• Conduct Advanced Therapy Products’ testing (e.g. flow cytometry, mycoplasma test, qPCR assay, endotoxin test, ELISA).

• Lead test method development and method validation.

• Participate in Pharmaceutical Quality System (PQS) activities including change control, deviation investigation, laboratory OOS investigation, CAPA and quality risk assessment.

• Other duties as assigned by the supervisor or management team.
   

Qualification and requirements:
 

• Holder of a bachelor’s degree or advanced degree in a discipline such as biotechnology, biomedical engineering, medical laboratory science and other similar disciplines, with a strong scientific background in cell biology and molecular biology, and at least 3 years of working experience at supervisory level in GMP quality control of pharmaceutical products.

• Preferable with knowledge and/or experience in QC of sterile pharmaceutical products, biological substances and products, active pharmaceutical ingredients, and/or investigational medicinal products.

• Preferably with knowledge and/or experience in conducting testing of Advanced Therapy Products (ATPs) or cell-based products, e.g. flow cytometry, mycoplasma test, qPCR assay, endotoxin test, ELISA.

• Interested to join the cell and gene therapy manufacturing and testing industry.

• Strong inter-personal skills, attention to details and a team player with self motivation.

• Excellent communication, problem solving, time management and prioritization skills.

• Proficiency in English and Chinese, and computer skills such as Office, Zoom/Teams etc.

• Possess the drive to succeed and to participate in the growth of an exciting, fast-paced company.

To apply, please email your CV and covering letter explaining why you want to work for us.