Website Innocare pharma
Main Responsibilities:
As CMC leader will lead and drive CMC-related activities for Innocare macromolecular drug products, including the process development, analytical, formulation, and manufacture.
Develop CMC strategies and oversee all CMC activities from preclinical development through commercialization.
Drive process improvements and efficiencies across different stages of development and clinical/commercial manufacture.
Supervise on selection, contract negotiation, management, and QC/audit of Contract Manufacturing Organizations (CMOs) for some pipelines.
Support IND, BLA filling by writing/reviewing regulatory materials or process changes (PD chapters) to ensure regulatory approval.
Review or edit cGMP batch records, CMC regulatory and Quality documents.
Responsible for hiring, training, supervising, evaluating, and managing employee performance in CMC function.
Qualifications:
PhD in biology, microbiology, biochemistry, biochemical engineering, or relevant disciplines.
At least 10 years of working experience in a pharmaceutical or biotechnology CMC/cGMP environment, including at least 3-year experience as CMC lead.
Experience with projects in clinical development, cGMP manufacturing and IND, CTA, and NDA filings.
Strong leadership capabilities with team management and talent development abilities.
Fluency in English and Mandarin preferred.
Contact: Please email: Abbie.Huang@Innocarepharma.com and mention that you saw this JD on the SAPA website.