Associate Director, Technical Services & Analytical MSAT

100 Eli Lilly and Company; Richmond (VA); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Pension

Health benefits

Job summary

Lilly is constructing an advanced manufacturing facility for monoclonal antibodies in Virginia and seeks an Associate Director to lead TS/MS/MSAT analytical support. You will oversee biologics processes, drive a high-performing team, and ensure regulatory-ready operations from startup through qualification and validation.

The role requires a strong background in biologics analytics, GMP manufacturing, and CMC regulatory experience, with onsite, Monday–Friday work and opportunities to shape a new

Qualifications

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

Responsibilities

• Lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes.
• TS/MS is responsible for ensuring manufacturing processes run reliably in a state of control through process monitoring.
• Build a diverse and capable TS/MS organization with capability, capacity and culture to operate the facility to high standards.
• Lead, develop and retain a high-performing team with a culture of technical excellence and continuous improvement.
• Coach, mentor and manage performance of direct reports to develop their full potential.
• Determine TS/MS staffing and resource needs to support startup and qualifications.
• Support development and implementation of robust control strategies to ensure regulatory compliance and operational excellence.
• Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and reports.
• Support the project team to deliver the facility ready to operate on schedule.

Skills

Analytical development

Biologics

CMC regulatory submissions

Team leadership

Process development

Education

BS or higher in biology/biochemistry/chemistry/chemical engineering

Job description

Lilly is constructing an advanced manufacturing facility for monoclonal antibodies in Virginia and seeks an Associate Director to lead TS/MS/MSAT analytical support. You will oversee biologics processes, drive a high-performing team, and ensure regulatory-ready operations from startup through qualification and validation.

The role requires a strong background in biologics analytics, GMP manufacturing, and CMC regulatory experience, with onsite, Monday–Friday work and opportunities to shape a new