Associate Director, CMC Operations & Change Control

Edgewise Therapeutics, Inc.; United States; On-site; USD 165,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Discretionary bonus plan

Stock option grants

Stock purchase plan

401(k) with match

Paid time off

Job summary

Edgewise Therapeutics, Inc. is seeking an Associate Director, Technical Operations to lead CMC change control and logistics across DS/DP, analytical, manufacturing, supply chain, and regulatory teams.

The role partners with QA, Regulatory Affairs, and external partners, and reports to the Senior Director of Manufacturing Sciences & Technology. You will drive cross-functional change control, optimize shipment planning, and ensure compliance with GMP/QMS while guiding teams through lifecycle

Qualifications

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Engineering, Biology, or related scientific discipline. Advanced degrees (MS, PharmD, or PhD) preferred.
• 7+ years of biotechnology, pharmaceutical development experience. 5+ years in CMC Small molecule development experience is required.
• Experience across DS/DP development, analytical development, and QMS.
• Significant experience within CMC orgs including Manufacturing, Supply Chain, and Regulatory affairs.

Responsibilities

• Lead all CMC change controls as the change owner.
• Coordinate change controls from inception through closure, with QA ownership.
• Assess impacts across technical, quality, regulatory, manufacturing, supply chain, and validation.
• Guide teams on change control documentation and strategy.
• Monitor change control metrics, timelines, and risks; report to leadership.
• Lead CMC shipment planning and logistics coordination; prepare shipping reports.

Skills

CMC knowledge

Project management

Cross-functional collaboration

Regulatory awareness

Quality systems

Education

Bachelor’s degree in chemistry/related

MS/PhD preferred

Tools

Veeva Vault QMS

TrackWise

MasterControl

Job description

Edgewise Therapeutics, Inc. is seeking an Associate Director, Technical Operations to lead CMC change control and logistics across DS/DP, analytical, manufacturing, supply chain, and regulatory teams.

The role partners with QA, Regulatory Affairs, and external partners, and reports to the Senior Director of Manufacturing Sciences & Technology. You will drive cross-functional change control, optimize shipment planning, and ensure compliance with GMP/QMS while guiding teams through lifecycle