Develop and review method transfer protocol, analytical methods verification and validation, equipment qualification, laboratory procedures, evaluation and implementation of new technologies.
Coordinate with Corporate and CGAM sites laboratory process improvements.
Perform routine and non-routine activities according to established SOPs with minimum supervision according to established SOPs.
Responsible for the arrangement, coordination and/or support of projects involving R&D, QC, Corporate and external customer as requested; ability to lead, write, execute and coordinate laboratories qualification/validation activities and test method validation.
Responsible for the oversight of laboratory computerized systems.
Identify continuous improvement initiatives, including workflow processes to improve productivity.
Perform duties as assigned by supervisor according to compliance and business needs.
Minimum 3 to 5 year relevant experience in the pharmaceutical / API industry.
Good knowledge of analytical / incoming testing (GC, HPLC, KF, NMR preferred); demonstrated experience in method verification / validation, laboratory investigation, equipment qualification and trouble-shooting.
Knowledge of cGMP concept (i.e. ICH guidelines, FDA, EMA, NMPA).
Fast learner with ability to adapt to changes, and with continuous improvement mindset; able to write and communicate well in English and in Chinese language.
CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in Riom (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees. Learn more about careers opportunities at CARBOGEN AMCIS at: www.carbogen-amcis.com/careers
CARBOGEN AMCIS AG is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development. Our integrated services for Drug Substances (DS) and Drug Products (DP) provide innovative solutions to support timely and safe drug development.