Sr. Manager, MSAT Protein Sciences Downstream - Remote

Overview

The Sr. Manager, MSAT Protein Sciences Downstream is an experienced manufacturing and processing subject matter expert with a focus on protein sciences and downstream process. The position is responsible for managing Iovance’s GMP manufacturing operations and contracted manufacturing operations centered on protein production and characterization, with a focus on downstream process. S/He will actively collaborate with Process Development, Manufacturing, Quality, Supply Chain, Regulatory, functions, in the US/EU with a focus on ex-US manufacturing operations.

In Short

• Subject matter expert in molecular biology, protein expression, purification, and biochemistry.
• Manage knowledge management related to product, process, and analytical.
• Support process and analytical strategy development and risk assessment.
• Build relationships with Contract Manufacturing Organizations.
• Manage technical transfer and improvement projects.
• Support regulatory CMC activities for clinical/commercial products.
• Liaise with Quality/Supply Chain on product disposition.
• Manage hiring and development of staff.
• Ensure operational readiness for manufacturing campaigns.
• Utilize operational excellence and communication skills to develop efficient systems.

Requirements

• A minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years experience in a relevant Life Science discipline.
• In-depth understanding of protein expression, characterization, and purification.
• Strong operational experience in a GMP manufacturing environment.
• Direct experience managing contract development/manufacturing organizations.
• Thorough understanding of biotherapeutics manufacturing.
• Demonstrated business and commercial focus.
• Experience working in a global business environment.
• Strong verbal and written communication skills.
• Willingness to travel globally for business needs.

Benefits

• Inclusive work environment.
• Equal opportunity employer.
• Support for accommodations in the application process.