Manager, Material Management

ABOUT eGENESISeGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. 
POSITION SUMMARYThe Manager, Material Management will be responsible for overseeing the qualification, lifecycle management, and compliance of raw materials used across eGenesis’ GMP operations. This role will ensure that materials used in donor production, manufacturing, and clinical programs meet regulatory, quality, and operational requirements.
This position will lead the evaluation and qualification of new materials, manage supplier-related quality activities, and oversee material change assessments to ensure compliance with GMP and regulatory expectations. The role will also strengthen raw material lifecycle management processes, supplier performance metrics, and cross-site material governance.
The Manager, Material Management will collaborate closely with Quality, Manufacturing, Supply Chain, and external vendors to ensure a robust and scalable material management program. This position will also work with additional operational support from teams at other eGenesis locations.

PRIMARY RESPONSIBILITIES

• Take ownership of material management responsibilities currently managed within the Quality organization and ensure continuity of operations
• Manage qualification and approval of new raw materials used across GMP operations
• Perform risk assessments and technical evaluations of raw materials to ensure suitability for intended use
• Lead vendor change evaluations and assess the impact of supplier or material changes on manufacturing and donor production processes
• Ensure raw materials meet internal specifications and regulatory expectations for GMP use
• Strengthen raw material lifecycle management including onboarding, qualification, change management, and retirement processes
• Develop and maintain supplier quality metrics and material performance tracking
• Support supplier qualification and collaborate with Supplier Quality on vendor oversight and audits when required
• Establish standardized material management procedures across sites
• Ensure traceability, documentation, and data integrity for all materials used in GMP operations
• Partner with Supply Chain and Manufacturing teams to ensure compliant material availability for clinical and operational needs
• Support investigations, deviations, and change controls related to materials and supplier performance
• Participate in internal and external audits and regulatory inspections related to materials and supplier oversight
• Contribute to the development and improvement of Quality Management System (QMS) procedures related to materials and supplier management
• Collaborate with cross-functional teams to ensure material specifications and requirements are aligned with process and program needs
• Support implementation of systems and tools used for material tracking and governance
• Drive continuous improvement initiatives related to supplier quality, material governance, and operational efficiency

BASIC QUALIFICATIONS

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline
• Minimum of 5 years of experience in Quality, Supplier Quality, Materials Management, or GMP operations within the biotechnology, pharmaceutical, or regulated life sciences industry
• Strong understanding of GMP requirements related to raw material qualification and supplier oversight
• Experience conducting material risk assessments and supplier evaluations
• Familiarity with regulatory expectations from FDA, EMA, and ICH guidelines related to materials and supplier quality
• Experience working with Quality systems such as deviations, CAPAs, change controls, and supplier qualification programs
• Excellent documentation, organization, and communication skills
• Experience with digital quality or inventory systems (e.g., Benchling, Veeva, ERP systems) is preferred
• Flexibility to travel up to 10% to support activities across IN, WI and MA sites

LEADERSHIP QUALIFICATIONS

• Organizational, staff mentorship, and time management skills with attention to details
• Ability to manage multiple priorities in a fast-paced and evolving environment
• Demonstrated ability to work cross-functionally with Quality, Manufacturing, and Supply Chain teams
• Strong analytical problem-solving, and critical-thinking skills
• Excellent communication skills with the ability to effectively communicate with internal teams and external partners
• Ability to drive process improvements and strengthen operational systems
• Experience mentoring and guiding team members in a collaborative environment

TOTAL REWARDSeGenesis is proud to offer competitive compensation including annual base salary, annual bonus, and opportunity for overtimeMedical insurance (up to 90% company paid)Dental insurance (up to 90% company paid)Vision insurance (100% company paid)401k with a company matchPaid time off and paid sick timePaid holidays