Senior Manager, External Supplier Operations

Principle Duties and Responsibilities Include:

• Support execution of external Drug Substance (DS) and Drug Product (DP) manufacturing programs in accordance with approved plans, timelines, supply requirements, and business priorities
• Coordinate technology transfer, supplier onboarding, and manufacturing readiness activities, including integrated schedules, milestones, dependencies, critical path activities, and deliverables
• Maintain detailed visibility to supplier commitments and proactively identify schedule risks, gaps, and issues that may impact program execution
• Lead internal supplier operations and manufacturing coordination meetings, including preparation, action tracking, decision documentation, and follow-up
• Coordinate internal and external cross-functional activities across Manufacturing Operations, MSAT, QA, Business, Supply Chain, SRM, Procurement, and supplier teams
• Partner with MSAT and other technical SMEs to incorporate technical activities and decisions into program plans and ensure technical issues are appropriately communicated and tracked
• Serve as a key operational interface with external suppliers, ensuring commitments, action items, and deliverables are clearly understood and progressed to completion
• Support Supplier Relationship Management (SRM) and Business stakeholders in monitoring supplier performance and resolving execution issues
• Develop and maintain manufacturing plans, schedules, dashboards, and status reports to provide clear visibility to program progress and alignment with the POR
• Track program risks, issues, assumptions, decisions, and dependencies; coordinate mitigation activities and escalate material risks as appropriate
• Monitor supplier performance against agreed timelines, deliverables, and KPIs and communicate significant trends or areas requiring attention
• Coordinate manufacturing readiness activities associated with technology transfer, start-up, validation, and clinical and commercial manufacturing
• Coordinate MBR/EBR review activities and other internal review and approval workflows, ensuring stakeholders remain aligned to established timelines
• Track manufacturing change controls, deviations, investigations, and other quality-related deliverables that may impact manufacturing schedules, working closely with QA and technical SMEs
• Provide operational and project management input into manufacturing-related scopes of work, contracts, and supplier deliverables in partnership with External Manufacturing leadership, SRM, Business, and Procurement
• Support financial and scope tracking for external manufacturing activities, including planned work, supplier deliverables, and changes to scope
• Prepare concise program updates for leadership, highlighting progress, key risks, decisions required, and actions needed to maintain execution
• Proactively identify potential schedule impacts and work with appropriate functional owners and suppliers to develop practical solutions
• Support commercial readiness by ensuring key manufacturing, technology transfer, and supplier deliverables are incorporated into integrated program plans and completed on schedule
• Contribute to continuous improvement of External Manufacturing processes, tools, and operating practices as the organization and supplier network evolve

Qualifications/Requirements:

• Minimum Bachelor's degree in scientific, engineering, technical, or related discipline
• Minimum 7 years of relevant experience in the biopharmaceutical industry, including experience in project, program, manufacturing, or external operations management
• Demonstrated experience working with contract development and manufacturing organizations (CDMOs) and managing external manufacturing activities from a program or operational perspective
• Experience supporting technology transfers, manufacturing programs, supplier onboarding, or other complex external manufacturing activities
• Working knowledge of biopharmaceutical manufacturing, preferably Drug Substance manufacturing, sufficient to effectively communicate with technical SMEs and external supplier personnel
• Demonstrated ability to manage complex schedules with multiple workstreams, dependencies, milestones, and cross-functional contributors
• Strong project and program coordination skills with demonstrated ability to establish structure, maintain accountability, and drive deliverables to completion
• Strong interpersonal and communication skills, with the ability to work effectively across technical, operational, business, and supplier organizations
• Ability to independently organize and prioritize multiple competing activities in a fast-paced, matrixed environment
• Demonstrated ability to identify risks and issues early, understand their potential program impact, and escalate appropriately
• Strong attention to detail and follow-through, particularly in tracking deliverables and ensuring commitments are closed
• Ability to understand technical discussions and translate complex information into clear project actions, decisions, timelines, and risks
• Experience working with cross-functional teams including Manufacturing Operations, MSAT, Quality, Supply Chain, Procurement, SRM, and external suppliers
• Experience in a small to mid-sized biotech environment preferred
• Experience supporting late-stage clinical or commercial manufacturing programs preferred
• Basic understanding of cGMP requirements and pharmaceutical quality systems preferred
• Proficiency in Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet

Core Competencies:

• External Supplier Execution: Ability to coordinate CDMO activities and maintain accountability for supplier commitments and deliverables
• Program Coordination: Creates structure around complex programs and drives activities toward completion
• Technical Fluency: Understands biopharmaceutical manufacturing sufficiently to engage credibly with technical teams without serving as the primary technical SME
• Communication: Clearly communicates program status, risks, decisions, and actions across technical and non-technical stakeholders
• Ownership: Proactively identifies what needs to happen next and drives follow-through with minimal direction
• Collaboration: Builds effective working relationships across Manufacturing Operations, MSAT, QA, SRM, Business, Supply Chain, PMO, and external partners
• Problem Solving: Identifies issues early, engages the appropriate stakeholders, and drives toward practical resolution
• Execution Discipline: Maintains attention to detail while keeping sight of broader program objectives and business priorities