External Manufacturing Organization (EMO) - Manager/ Sr Manager

Essential Duties

• Executing for Results
• The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.
• Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.
• A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.
• Leadership and Stakeholders
• The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from colleagues and partners.
• High emotional intelligence (EQ) to recognize time to de-escalate tension, find solutions which incorporate team’s insight, smooth egos, and maintain professionalism to advance our goals.
• A leader who is self-reflective and aware of their own limitations; leads by example and drives performance with an attitude of continuous improvement by being open to feedback and self-improvement.
• Relationships and Influence
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• An ability to inspire trust and followership in others through compelling influence, passion in their beliefs, and active drive.
• Encourages others to share the spotlight and visibly celebrates and supports the success of the team.
• Creates a sense of purpose and meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole.

Additional Responsibilities

• Manage day-to-day operations with assigned CMOs, ensuring alignment with production schedules and business objectives
• Build and maintain strong, collaborative relationships with external partners
• Lead regular business reviews and performance discussions
• Ensure timely production, release, and delivery of drug substances and/or drug products
• Monitor manufacturing performance metrics (e.g., yield, deviations, on-time delivery)
• Partner with Supply Chain to support demand planning and inventory management
• Ensure all manufacturing activities comply with GMP and global regulatory requirements
• Support investigations, deviations, CAPAs, and change controls in collaboration with Quality teams
• Participate in audits and regulatory inspections as needed
• Provide oversight for tech transfer, process validation, and lifecycle management
• Collaborate with MSAT teams on process improvements
• Troubleshoot manufacturing issues and drive resolution with CMOs
• Lead cross-functional initiatives related to external manufacturing
• Track milestones, risks, and deliverables for CMO-related projects
• Ensure effective communication across internal teams (Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&D)
• Identify opportunities to optimize cost, efficiency, and quality
• Implement best practices and operational improvements across CMO network