Senior Manufacturing Manager - Early Phase Trials
Proclinical has partnered with a large pharmaceutical organisation in Singapore for a Senior Manufacturing Manager to lead Early Phase Trials. This would be the ultimate opportunity to effectively contribute towards the improvement of medicine.
- Oversee the daily management of the workshop;
- Will be expected to organise and run workshops for production and quality risk control;
- Responsible for organizing the drafting, review, revision and change of workshop production process regulations;
- Supervise and manage the implementation of sanitation and cleaning of workshop processes, environment, personnel, equipment and materials;
- In accordance with GMP requirements, conduct a comprehensive inspection and self-inspection of the workshop, and supervise the completion of defect rectification;
- Supervise the implementation of workshop equipment verification, cleaning verification, process verification and other related verifications;
- You will be expected to supervise and review batch production records;
- Responsible for the management and implementation of workshop process technology innovation, process plan improvement and plan;
- Participate in the preparation of user requirements for new workshops, equipment user requirements and personnel recruitment.
- Assist in the formulation of factory/laboratory construction project plans and cooperate with the relevant procedures of construction projects.
- Bachelor degree or above, major in biopharmaceuticals;
- More than 5 years of experience in the biopharmaceutical industry, familiar with the production process of vaccines or recombinant biological products, and rich experience in the production and management of vaccines or recombinant biological products.
- Engineering management experience in workshop construction is preferred
- Possess good production site management concepts and management methods, good process optimization, overall organization, coordination and strong leadership capabilities;
- Have good communication skills and expression skills in Chinese and English;
- Understand the Chinese and EU GMP regulations and technical specifications, and have received relevant training on drug production management, equipment management, quality management and other laws and regulations
- Mandatory to speak Chinese to liaise with Chinese counterparts.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.