Associate Director, Technical Services & MSAT Analytics

BioSpace; Richmond (VA); Vor Ort; USD 123.000 - 180.000; Vollzeit

Benefits dieser Stelle

Company bonus

401(k) plan

Comprehensive benefits

Vacation benefits

Zusammenfassung

Lilly is constructing a monoclonal antibody and bioconjugate facility in Goochland County, Virginia. The Associate Director – TS/MS / MSAT Analytical Support will lead a technical organization ensuring robust biology and chemistry across manufacturing processes.

You will build the team, drive site startup to GMP manufacturing readiness, coach staff, oversee documentation, and ensure regulatory compliance through lean, digitally enabled operations.

Qualifikationen

• BS or higher in biology, biochemistry, chemistry, chemical engineering, or 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

• Lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions.
• Support site leadership to build a diverse TS/MS organization with 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

Analytical development

Leadership

CMC submissions

Biologics

Regulatory inspections

Ausbildung

BS in biology/biochemistry/chemistry/chemical engineering

MS/PhD preferred

Jobbeschreibung

Lilly is constructing a monoclonal antibody and bioconjugate facility in Goochland County, Virginia. The Associate Director – TS/MS / MSAT Analytical Support will lead a technical organization ensuring robust biology and chemistry across manufacturing processes.

You will build the team, drive site startup to GMP manufacturing readiness, coach staff, oversee documentation, and ensure regulatory compliance through lean, digitally enabled operations.