Genezen Laboratories
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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 Automation Engineer II handles the administration of facilities and process automation, providing support and troubleshooting services. Responsibilities include designing and implementing automation systems, leading projects for equipment modifications, and developing test scripts and automation procedures.
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.
The Upstream Process Development Scientist will develop and optimize processes for producing various viral vectors. Responsibilities include designing experiments, analyzing data, collaborating with teams, and ensuring compliance with regulatory standards. The role emphasizes process scale-up and optimization to improve yield and quality while maintaining communication with clients and internal teams.
The Downstream Process Development Scientist will focus on developing and optimizing purification processes for gene therapy viral vectors. Responsibilities include scaling processes, conducting experiments, analyzing data, collaborating with cross-functional teams, and ensuring compliance with client and regulatory standards.