Senior Associate Director, Analytical Sciences - Tech Ops

NCBiotech; Durham (NC); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

401k

Career training

Collaborative environment

Cutting-edge research

Job summary

NCBiotech is seeking an Associate Director of Analytical Sciences to shape the analytical strategy for biologics development and lead late-stage programs. You will oversee method validation, comparability, and control strategies while aligning with regulatory expectations and device-friendly timelines.

The role reports to the Senior Director, Tech Ops, and requires strong leadership across cross-functional teams, external CROs, and CDMOs to enable clinical development and eventual

Qualifications

• Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years in pharma/biotech analytical CMC.
• Or B.S./M.S. with 12+ years in pharma/biotech analytical CMC.
• Experience advancing biologic products through IND and clinical development.
• Experience leading multidisciplinary CMC teams in a matrix environment.
• Experience managing CDMOs and external development partners.
• Strong understanding of CMC regulatory expectations for biologic products.

Responsibilities

• Establish and evolve the Analytical Sciences strategy across the portfolio.
• Provide scientific leadership for analytical lifecycle management, comparability, method validation, and control strategy development.
• Collaborate with cross-functional teams to ensure phase-appropriate development and regulatory readiness.
• Lead external partnerships, CRO oversight, and technology evaluations.
• Mentor scientists and build a high-performing analytical organization.

Skills

Communication

Leadership

Project management

Matrix leadership

Regulatory knowledge

CDMO management

Education

Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences

B.S./M.S. in Chemical/Biochemical Engineering or related Biological Sciences

Job description

NCBiotech is seeking an Associate Director of Analytical Sciences to shape the analytical strategy for biologics development and lead late-stage programs. You will oversee method validation, comparability, and control strategies while aligning with regulatory expectations and device-friendly timelines.

The role reports to the Senior Director, Tech Ops, and requires strong leadership across cross-functional teams, external CROs, and CDMOs to enable clinical development and eventual