Genezen Laboratories
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Jobs at Genezen Laboratories
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Responsible for the transition of technology from development to production environments, ensuring seamless scaling and adaptation to GMP production for viral vectors. Duties include documentation, data analysis, collaboration with cross-functional teams, and maintaining compliance with regulatory standards.
The Process Engineer is responsible for supporting engineering and technical disciplines related to gene therapy processes. Key responsibilities include project management, compliance monitoring, quality control, and implementing safety management systems. This role emphasizes workflow optimization and the enhancement of facilities, ensuring adherence to FDA standards while driving continuous improvement initiatives.
The individual will establish processes in Downstream Process Development, ensuring scalable platform production of viral vectors. Responsibilities include process optimization, monitoring performance, maintaining compliance with regulations, and collaborating with stakeholders. The role requires leading design for single-use systems and serving as a subject matter expert for audits.
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 Head of Business Development will implement overall business development strategies, manage a team, and drive sales and revenue goals. Responsibilities include developing partnerships, overseeing marketing strategies, and ensuring compliance with industry regulations. The position also involves extensive interaction with clients and requires strong negotiation skills and strategic thinking.
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 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 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.