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The Scientist in Quality Systems enhances ProBio’s quality systems by ensuring compliance with GMP regulations for clinical and commercial Cell and Gene Therapy products. Responsibilities include quality assurance reviews, supporting investigations and CAPA processes, and collaborating with internal teams to improve GxP compliance.
The Sr. Product Manager will be the key product owner for gene and cell therapy services, performing launch planning, market trend analysis, and product development roadmapping. They will lead business initiatives, collaborate with stakeholders, and advocate for customer needs.
The GMP Logistics Specialist is responsible for overseeing domestic and international logistics processes including shipment coordination, customs clearance, and maintaining compliance with GMP standards. The role involves collaboration with cross-functional teams, handling shipping records, and managing freight invoices while adhering to cGMP policies.
The Office Admin Coordinator will oversee office administration tasks, manage staff, coordinate company events, handle travel arrangements, and budget oversight. The role requires proactive management to ensure efficient operations, support various departments, and implement cost-saving initiatives.
The Legal Assistant will support the legal team at GenScript by ensuring compliance with corporate obligations of foreign subsidiaries, preparing and maintaining corporate compliance documentation, drafting legal documents, and assisting in the formation of new legal entities.
The QC Associate Scientist will perform a variety of analytical tests to support QC processes for clinical trial materials. Responsibilities include ensuring compliance with cGMP requirements, conducting method development and validation, and optimizing QC department initiatives. The role requires strong technical knowledge and the ability to support quality control testing for various biological products.
The QA Technical Operations Specialist is responsible for managing supplier quality activities, overseeing the GMP supplier qualification program, conducting quality assessments, managing vendor complaints, and ensuring compliance with quality standards. The role involves data analysis for supplier performance, driving improvements, managing audits, and supporting validation and regulatory inspections.
The Office Admin Supervisor is responsible for overseeing office operations, managing administrative services, coordinating travel arrangements, supporting external personnel, leading events, managing office supplies, supervising billing and data management, and providing operational support across departments.
The Bioprocess Specialist in Downstream Processing performs key tasks including preparation of solutions, chromatography, filtration, and drug formulation. This role requires adherence to regulatory standards and collaboration with departments on gene therapy manufacturing.
The Sr. Automation Engineer is responsible for managing the SCADA system and automation systems in GMP manufacturing. Responsibilities include installation, maintenance, validation of systems, and adherence to regulatory requirements. The role involves collaboration with internal departments and supports automation for bioprocess equipment and change management processes.
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