Senior Manager, External Supplier Operations

Principle Duties And Responsibilities

• Support execution of external Drug Substance (DS) and Drug Product (DP) manufacturing programs in accordance with approved plans, timelines, supply requirements, and business priorities
• Cook up 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
• Work closely with 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
• Contribute to continuous improvement of External Manufacturing processes, tools, and operating practices as the organization and supplier network evolves

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
• 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

Pay

We are currently anticipating the base salary for Senior Manager External Supplier Operations role could range from $165,000 to $180,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis).