Materials Specialist - MFG

Role Summary

Materials Specialist - MFG responsible for planning and maintaining the lifecycle of materials used in bulk drug production, with involvement in end-to-end lifecycle management, supplier coordination, and cross-functional collaboration. Travel may be required.

Responsibilities

• Manage end-to-end lifecycle management of Single-Use Technologies, Raw Materials, Processing Aids, and Manufacturing Support Materials
• Onboarding of new materials and suppliers
• Participate in on-site audits
• Facilitate form, fit, function assessments
• Material retirement as business needs evolve
• Material Specification revision/approval
• Develop and manage business analytics to ensure continuous supply of material for Process Areas
• Responsible for cut-over strategies of Process Area material for material revisions
• Trend material failures to drive material improvement
• Coordinate with cross-functional teams to support Second Source/Replacement Sourcing of materials
• Oversee Supplier Change Notification evaluations for Bulk Manufacturing
• Participate in PFMEA/Risk Assessments/Regulatory Assessments with cross-functional teams
• Coordinate Material Gap Assessments for new programs transferred into Process Areas
• Participate in supplier relationship meetings with vendors
• May require some travel
• Perform other duties as assigned

Qualifications

• Required: BS/BA in Business or related field and 2+ years of experience or equivalent combination of education and experience
• Preferred: Experience in strategic planning or project management
• Preferred: Biopharma commercial-scale manufacturing knowledge

Skills

• Ability to handle multiple projects and priorities with exceptional organizational and time management skills
• Effective communication with peers and leadership
• Ability to build effective working relationships across the organization
• Ability to facilitate meetings and projects with cross-functional teams
• Ability to operate independently within a tight deadline environment

Education

• BS/BA in Business or related field (required for all levels)

Additional Requirements

• On-site work may be required