Associate Manufacturing Outsourcing Manager

The Associate Manufacturing Outsourcing Manager is accountable for effective supply chain management of cell banks, drug substance and drug product sourced from external Contract Manufacturing Organizations (CMOs). The Associate Manager is responsible for project coordination with external manufacturing partners to ensure product supply for MacroGenics' portfolio. The Associate Manufacturing Outsourcing Manager collaborates cross-functionally with key MacroGenics stakeholders including CMC Project Management, BioPharmaceutical Development, Quality Control, Quality Assurance, Clinical Supply Operations and MSAT to drive external manufacturing activities.

Responsibilities and Job Duties:

• Supports external manufacturing relationships and interactions between MacroGenics teams and the CMO to ensure on-time production, release, and shipments.
• Monitors detailed project timelines for outsourcing activities and ensures transparent communication to project teams.
• Manages the internal cross-functional external production meeting by scheduling and hosting meetings, preparing agendas and meeting minutes.
• Coordinates shipments between MacroGenics and the CMO by preparing documentation and coordinating with internal and external stakeholders.
• Updates the internal cross-portfolio manufacturing outsourcing production plan.
• Updates and maintains manufacturing outsourcing team site.
• Authors and reviews supply chain maps for clinical portfolio products.
• Assists converting paper forms to electronic/fillable PDF formats.
• Performs additional responsibilities to support supply chain activities as designated by management.

Minimum Qualifications

Education

Bachelor's degree in a relevant technical or scientific discipline

Experience

At least 3 years' experience in biopharma/pharma supply chain, GMP manufacturing or process development

Knowledge, Skills and Abilities

• Excellent verbal and written communication skills
• Self-motivated and results-oriented with initiative to complete tasks proactively
• Well-organized with ability to effectively establish priorities and manage multiple responsibilities, tasks, and projects simultaneously in a fast-paced environment
• Capacity to organize assignments and work within deadlines
• Strong collaboration skills, ability to develop working relationships with colleagues at all levels of the organization
• Strong attention to detail
• Strong computer skills including versatility with Microsoft Office Suite, Adobe Acrobat
• Willing to learn new areas of expertise as required for the position

Preferred Qualifications

• Knowledge of GMP requirements
• Preference for direct experience in one or more areas of biopharmaceutical manufacturing (drug substance or aseptic fill/finish) or process development (cell culture, purification, drug product)
• Preference for related experience in project management
• Prior use of SAP or similar ERP system
• Prior use of project management tools (e.g. Microsoft Project, Smartsheet)

Supervisory Responsibilities

None