Analytical MSAT Director for Biologics Manufacturing

Eli Lilly and Company; Richmond (VA); Vor Ort; USD 123.000 - 180.000; Vollzeit

Zusammenfassung

Eli Lilly and Company is seeking an Associate Director – TS/MS/ MSAT with responsibility for Analytical Support in the Virginia GMP manufacturing startup. You will lead a cross-functional team to ensure robust biology and chemistry processes, driving process monitoring, control strategies, and regulatory readiness.

The role requires 10+ years in analytical development for biologics, 5+ years in people leadership, and experience with CMC submissions.

Qualifikationen

• BS or higher in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline.
• 10+ years of experience in analytical development, characterization, or technical support for biologics (mAbs/bioconjugates), including 5+ years in a people leadership role
• Experience in analytical method development for biologic drug substance and drug product
• Experience supporting or authoring CMC regulatory submissions

Aufgaben

• Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence
• Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
• Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential, and the team is structured for long-term success
• Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
• Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
• Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
• Support the project team to deliver the facility to the site lead team ready to operate and on schedule

Kenntnisse

Leadership

Communication

Teamwork

Adaptability

Ausbildung

BS or higher in biology, biochemistry, chemistry, chemical engineering, or related scientific discipline

Advanced degree (MS or PhD) preferred

Jobbeschreibung

Eli Lilly and Company is seeking an Associate Director – TS/MS/ MSAT with responsibility for Analytical Support in the Virginia GMP manufacturing startup. You will lead a cross-functional team to ensure robust biology and chemistry processes, driving process monitoring, control strategies, and regulatory readiness.

The role requires 10+ years in analytical development for biologics, 5+ years in people leadership, and experience with CMC submissions.