Associate Director, Technical Operations

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

The Associate Director, Technical Operations provides leadership for key CMC operational activities, supporting cross-functional alignment and execution across Edgewise development programs. This role leads CMC change control activities throughout the product lifecycle, serving as the primary coordinator for changes impacting Drug Substance (DS), Drug Product (DP), Analytical, Manufacturing, Supply Chain, and Regulatory functions.

The position acts as a key liaison among CMC, Quality Assurance, Regulatory Affairs, Technical Operations, and Supply Chain teams, as well as external manufacturing and testing partners. Responsibilities also include oversight of CMC shipping and logistics activities, including shipment planning, tracking, and operational coordination.

This role requires strong cross-functional collaboration to ensure alignment of technical, quality, regulatory, and operational objectives and reports directly to the Senior Director, Manufacturing Sciences & Technology (MS&T)

Essential Job Duties and Functions:

• Serve as the change owner and lead all CMC-related change controls.
• Initiate, develop, coordinate, and track change controls from inception through closure.
• Ensure appropriate assessment of CMC technical, quality, regulatory, manufacturing, supply chain, and validation impacts.
• Partner closely with QA while maintaining CMC ownership of technical change strategy and implementation.
• Establish processes that improve consistency, compliance, and efficiency of change control management.
• Drive proactive identification of activities requiring change controls through participation in a broad range of forums and team meetings.
• Provide guidance to functional teams regarding change control requirements and expected documentation.
• Collaborate with QA to monitor change control metrics, timelines, and risks and provide visibility to leadership.

CMC Logistic Operations Leadership

• Provide operational leadership for CMC shipment planning and coordination.
• Prepare and review shipping reports and associated documentation.
• Coordinate shipment activities involving CMOs, CROs, testing laboratories, and distribution partners.
• Coordinate shipment-related activities to ensure appropriate planning, documentation, and alignment with project objectives.
• Identify opportunities to improve shipment planning, reporting, and logistics workflows.
• Support broader MS&T operational priorities and special projects as needed.
• Coordination & Stakeholder Engagement
• Represent CMC Change Control at project team and Change Control Review Board (CCRB) meetings.
• Serve as a key point of contact between CMC and QA regarding change implementation.
• Escalate risks, delays, and compliance issues to senior leadership.
• Drive continuous improvement initiatives related to change control and logistics management.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.
• Travel 25 % including all company retreats

Required Education, Experience and Skills:

• 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.
• Ideal candidate should demonstrate as follows:
• Demonstrate strong end-to-end knowledge of the CMC drug development lifecycle, from early development through commercialization.
• Demonstrate experience supporting and integrating activities across:
• Drug Substance (DS) development, process validation and manufacturing
• Drug Product (DP) development, process validation and manufacturing
• Analytical development, testing, validation, and lifecycle management
• Significant experience within CMC organizations, including R&D Development, Technical Operations, Manufacturing and Supply Chain
• Direct experience leading or coordinating GMP Change Controls, including cross-functional impact assessments and implementation planning.
• Experience collaborating with Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and external partners.
• Experience supporting shipping coordination, logistics planning, shipment execution, and preparation of shipping reports.
• Deep understanding of pharmaceutical Quality Management Systems (QMS) and GMP requirements.
• Hands‑on experience with electronic Quality Management Systems such as Veeva Vault QMS, TrackWise, MasterControl, or equivalent platforms.
• Experience managing Change Controls, Deviations, CAPAs, Risk Assessments, and related quality records within a QMS environment.
• Working knowledge of cGMP regulations, ICH guidelines, FDA, EMA, and global regulatory expectations.
• Strong understanding of change management principles and regulatory impact assessments throughout the product lifecycle.
• Excellent project management, communication, and stakeholder management skills.

Salary range: $165,000-$195,000, title and salary commensurate with experience.