ABOUT eGENESIS
eGenesis 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 SUMMARY
The 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 operationsManage qualification and approval of new raw materials used across GMP operationsPerform risk assessments and technical evaluations of raw materials to ensure suitability for intended useLead vendor change evaluations and assess the impact of supplier or material changes on manufacturing and donor production processesEnsure raw materials meet internal specifications and regulatory expectations for GMP useStrengthen raw material lifecycle management including onboarding, qualification, change management, and retirement processesDevelop and maintain supplier quality metrics and material performance trackingSupport supplier qualification and collaborate with Supplier Quality on vendor oversight and audits when requiredEstablish standardized material management procedures across sitesEnsure traceability, documentation, and data integrity for all materials used in GMP operationsPartner with Supply Chain and Manufacturing teams to ensure compliant material availability for clinical and operational needsSupport investigations, deviations, and change controls related to materials and supplier performanceParticipate in internal and external audits and regulatory inspections related to materials and supplier oversightContribute to the development and improvement of Quality Management System (QMS) procedures related to materials and supplier managementCollaborate with cross-functional teams to ensure material specifications and requirements are aligned with process and program needsSupport implementation of systems and tools used for material tracking and governanceDrive 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 disciplineMinimum of 5 years of experience in Quality, Supplier Quality, Materials Management, or GMP operations within the biotechnology, pharmaceutical, or regulated life sciences industryStrong understanding of GMP requirements related to raw material qualification and supplier oversightExperience conducting material risk assessments and supplier evaluationsFamiliarity with regulatory expectations from FDA, EMA, and ICH guidelines related to materials and supplier qualityExperience working with Quality systems such as deviations, CAPAs, change controls, and supplier qualification programsExcellent documentation, organization, and communication skillsExperience with digital quality or inventory systems (e.g., Benchling, Veeva, ERP systems) is preferredFlexibility 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 detailsAbility to manage multiple priorities in a fast-paced and evolving environmentDemonstrated ability to work cross-functionally with Quality, Manufacturing, and Supply Chain teamsStrong analytical problem-solving, and critical-thinking skillsExcellent communication skills with the ability to effectively communicate with internal teams and external partnersAbility to drive process improvements and strengthen operational systemsExperience mentoring and guiding team members in a collaborative environment
TOTAL REWARDS
eGenesis is proud to offer competitive compensation including annual base salary, annual bonus, and opportunity for overtime
Medical insurance (up to 90% company paid)
Dental insurance (up to 90% company paid)
Vision insurance (100% company paid)
401k with a company match
Paid time off and paid sick time
Paid holidays
