CMC Operations Lead – Change Control & Logistics

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

Job summary

Edgewise Therapeutics, Inc. is seeking an Associate Director of Technical Operations to lead CMC change control across DS/DP, Analytical, Manufacturing, and Supply Chain programs. The role coordinates QA, Regulatory, and external partners to ensure compliance and timely execution.

The position oversees CMC shipping/logistics, ship plan reviews, and reporting, while aligning with MS&T priorities. Strong cross-functional collaboration and GMP/QMS expertise are essential for success.

Qualifications

• Bachelor’s degree in chemistry or related field; advanced degrees preferred.
• 7+ years biotechnology/pharma development experience; 5+ years in CMC small molecule development.
• Experience leading GMP Change Controls and cross-functional impact assessments.
• Strong knowledge of cGMP, ICH, FDA/EMA regulatory expectations.
• Hands-on experience with QMS platforms (Veeva/MasterControl/TrackWise).

Responsibilities

• Lead all CMC-related change controls end-to-end.
• Coordinate shipping logistics and reporting for CMO/CRO partners.
• Partner with QA, Regulatory, Manufacturing, and Supply Chain to ensure lifecycle alignment.
• Escalate risks and drive continuous improvement.
• Represent CMC in CCRB meetings and project teams.

Skills

Cross-functional leadership

Program management

Communication

Regulatory knowledge

Problem solving

Education

Bachelor's degree in Chemistry/Pharma

Advanced degree preferred (MS/PhD)

Tools

Veeva Vault QMS

TrackWise

MasterControl

Job description

Edgewise Therapeutics, Inc. is seeking an Associate Director of Technical Operations to lead CMC change control across DS/DP, Analytical, Manufacturing, and Supply Chain programs. The role coordinates QA, Regulatory, and external partners to ensure compliance and timely execution.

The position oversees CMC shipping/logistics, ship plan reviews, and reporting, while aligning with MS&T priorities. Strong cross-functional collaboration and GMP/QMS expertise are essential for success.