Associate Director, External Manufacturing & CMC

Inside Higher Ed; Philadelphia (Philadelphia County); On-site; USD 100,000 - 375,000; Full time

Job summary

A leading biopharmaceutical organization is seeking an Associate Director to lead external manufacturing projects at their Gene Therapy Program. The successful candidate will be responsible for overseeing the development of Chemistry Manufacturing Control plans and collaborating with Contract Manufacturing Organizations. The position requires a Master's degree in a related field and extensive experience in biopharmaceutical manufacturing, with a focus on biologics and viral vectors.

Qualifications

• 5-7 years of experience in processes to make biologics, viral vectors, or vaccines.
• Experience with planning and managing CMC aspects of biopharmaceutical development.
• Familiar with current issues and Regulatory requirements related to manufacturing.

Responsibilities

• Develop external manufacturing plans and lead CMC cross-functional projects.
• Monitor CMC process transfer and manage budgets at CMOs.
• Create comprehensive risk management plans for production.

Skills

Biopharmaceutical manufacturing

Process and analytical development

Project management

Cross-functional communication

Risk management

Education

Master's degree in Chemical or Biomedical Engineering

Tools

Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook)

Visio and JMP

Job description

A leading biopharmaceutical organization is seeking an Associate Director to lead external manufacturing projects at their Gene Therapy Program. The successful candidate will be responsible for overseeing the development of Chemistry Manufacturing Control plans and collaborating with Contract Manufacturing Organizations. The position requires a Master's degree in a related field and extensive experience in biopharmaceutical manufacturing, with a focus on biologics and viral vectors.