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The QC Analyst will perform quality control reviews of various assays, ensuring compliance with GxP requirements and supporting investigations and validations in a regulated lab environment.

The CDMO Manager oversees contract manufacturing operations, ensuring GMP compliance, production efficiency, and quality standards. Responsibilities include site management, supply chain coordination, cost management, and risk mitigation, along with continuous improvement initiatives. The role demands strong leadership and extensive experience in manufacturing management, particularly in the biologics sector.

Lead quality assurance activities for cell and viral banks and drug products, ensuring compliance with cGMP and regulatory requirements, and collaborate cross-functionally for lot disposition.

The Principal Scientist will optimize AAV downstream processes, lead purification development, support regulatory compliance, and collaborate across functions for gene therapy programs.

Support design and execution of clinical development activities for ophthalmology trials: protocol writing, vendor/CRO oversight, medical monitoring, data review/interpretation, regulatory document contributions, and cross-functional collaboration.

The QA Manager, Document Control will oversee Document Control and quality system maintenance, system administration of MasterControl EQMS, training, and managing controlled documents.

The Clinical Data Manager oversees data management activities across clinical studies, ensuring data compliance and quality from start-up to closure, while managing CRO vendors and leading the data management team.