Executive Director, Biologics Production
The Executive Director of Biologics Production is responsible for the company’s overall manufacturing activities, the manufacturing of phase III clinical grade biopharmaceuticals, BLA filings, and the manufacturing of post-marketing products.
· Oversee company’s entire manufacturing activities, including cell culture, purification, formulation and facility management.
· Responsible for the manufacture of phase III clinical grade biopharmaceuticals, BLA filings, and the manufacture of marketed products.
· Streamline team responsibilities and troubleshoot issues in manufacturing process.
· Operate CMO services, responsible for building new facilities if needed.
· Master’s degree or higher in cell biology, bio-engineering, bio-pharmaceutical and other related fields.
· Ability to communicate in Mandarin.
· A minimum of 5 years of experience in managing a manufacture facility.
· Track record of BLA filing and product approval. Familiar with regulatory policies of BLA filing to FDA/CFDA.
· Experience in building manufacture facility.
· Familiar with large-scale mammalian cell culture, purification, formulation and facility management.