Genezen Laboratories
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The Technology Transfer Scientist I is responsible for ensuring smooth transitions of viral vector processes to manufacturing. This involves document management, analyzing process performance, and working with cross-functional teams to ensure compliance with regulatory standards while optimizing processes. The role requires strong organizational skills and technical expertise.
The Process Engineer will manage engineering projects for gene therapy processes, focusing on workflow optimization, compliance with FDA and EU standards, and continuous improvements. Responsibilities include project management, quality control, and ensuring adherence to safety and environmental protocols while driving operational efficiency.
The role involves directing the development of processes in Downstream Process Development within a gene therapy context. Responsibilities include process optimization, monitoring performance, maintaining safety compliance, and serving as a subject matter expert during audits. Strong collaboration with stakeholders and technical expertise in bioprocessing, GMP, and regulatory aspects are essential to ensure product safety and quality.
The Program Manager supports client programs through process development and GMP manufacturing of gene therapy viral vectors, acting as the primary contact between clients and the project team. Responsibilities include managing project schedules, ensuring client satisfaction, tracking project progress, resolving issues, and building strong client relationships.
The Quality Systems Lead will enhance the Quality Management System (QMS), focusing on electronic support, risk assessments, inspection readiness, and compliance. Responsibilities include managing the QMS platform, facilitating training, conducting audits, and supporting continuous improvement initiatives. The role demands a proactive individual to ensure regulatory compliance and improve quality systems across the organization.
The Sr. Procurement Specialist at Genezen is responsible for managing GMP procurement of materials and vendor relationships, ensuring compliant material delivery, and optimizing inventory costs. This role involves working collaboratively with internal teams and external suppliers while adhering to cGMP guidelines.
The Director of Technology Transfer will oversee cross-functional teams ensuring the transition of gene and cell therapy products from clinical development to commercial manufacturing, providing technical leadership, mentoring staff, and ensuring regulatory compliance.