Associate Director, Technical Operations

CMC Change Control Leadership

• 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

• 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.