A leading biotechnology company is seeking an Associate Director/Director for Upstream MSAT. This remote role involves overseeing biopharmaceutical drug manufacturing processes at contract manufacturers. The ideal candidate will have a PhD/MS in chemical engineering and over 10 years of experience in the biopharmaceutical industry, focusing on cell culture processes and regulatory filings. A collaborative attitude is essential as the role includes cross-functional team leadership and infrequent travel opportunities.
Qualifications
10+ years of industrial experience in the biopharmaceutical industry.
Experience in developing cell culture processes for biopharmaceuticals.
Understanding of cGMP for biopharmaceuticals.
Responsibilities
Support Drug Substance commercial manufacturing and technology transfer.
Prepare and review CMC documentation for regulatory filings.
Lead strategy and execution of process validation and improvement.
Skills
Cell culture processes
Technology transfer
Process scale-up
Project management
Cross-functional collaboration
Education
PhD/MS in chemical engineering or related areas
Job description
A leading biotechnology company is seeking an Associate Director/Director for Upstream MSAT. This remote role involves overseeing biopharmaceutical drug manufacturing processes at contract manufacturers. The ideal candidate will have a PhD/MS in chemical engineering and over 10 years of experience in the biopharmaceutical industry, focusing on cell culture processes and regulatory filings. A collaborative attitude is essential as the role includes cross-functional team leadership and infrequent travel opportunities.