Director, Biologics Analytical

📋 Description

• Provides leadership, strategic guidance and talent development for groups of highly skilled
• Defines and communicates industry-leading analytical strategies for mAbs, multi-specifics, ADCs and
• Familiar with commercial manufacturing and QC testing and able to be a partner in strategic
• Responsible for development, validation and transfer of analytical methods to support pipeline
• Establishes industry-leading analytical capabilities to support CMC process development, technology
• Solves difficult and highly complex technical issues in an evolving regulatory landscape.

🎯 Requirements

• PhD with at least 10 years of relevant pharma/biotech industry experience or master’s degree with
• Proven experience leading a CMC development organization, such as analytical development, drug
• Skilled in analytical method development, validation, transfer and troubleshooting for biologics.
• In depth knowledge in relevant regulations, interactions with regulatory agencies, and deep NDA and
• Extensive experience and solid understanding of the various scientific disciplines, including
• Demonstrated record of success leading strategic initiatives and new technology

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Eligible to participate in long-term incentive programs.