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The Senior Manager, Form/Fill leads a team ensuring compliance with regulations and operational efficiency in the production process. They develop departmental plans, manage staff, and support continuous improvement projects while maintaining safety and quality standards.
The Associate Scientist will perform analytical R&D tasks including method development, validation, and testing in compliance with regulations. Responsibilities include technical review of documents, analyzing raw and finished products, operating various analytical instruments, managing data with Empower software, and assisting in method transfers and validations under supervision.
The Scientist, Protein Purification is responsible for purifying and characterizing antibodies and related protein formats to support the generation of antibody-drug conjugates. Key duties include conducting antibody purifications, optimizing methods, and developing scalable purification processes for biotherapeutics. The role emphasizes collaboration within a scientific team to meet production timelines and ensure high-quality results.
The EHS&S Coordinator will assist in the day-to-day Environmental, Health, Safety, and Security functions at the site. Responsibilities include compliance with safety regulations, conducting training, performing workplace inspections, and ensuring hazard correction. The role supports the safety of employees and adherence to environmental standards.
The QA/RA Compliance Specialist ensures compliance with pharmaceutical regulations by managing change controls, preparing regulatory filings, and collaborating with various departments. Responsibilities include assisting in SOP development, supporting audits, and liaising with customers.
The Administrative Coordinator will provide comprehensive administrative support to the leadership team, manage schedules, coordinate events and meetings, arrange travel, and maintain office organization. They will serve as a point of contact for internal and external interactions while ensuring confidentiality and professionalism in a fast-paced environment.
The QA Product Manager acts as a customer liaison, focuses on quality and compliance, and oversees Quality Assurance for technical documents. Responsibilities include generating quality metrics, providing QA technical recommendations, supporting audits, and ensuring compliance with cGMP requirements.
The Documentation Specialist manages and maintains quality documentation in compliance with SOPs, oversees Document Change Requests, compiles materials for qualifications, and supports project teams across departments to ensure adherence to quality standards.
The Senior Process Scientist role involves supporting technical transfer and process development for commercial products, acting as a subject matter expert in manufacturing investigations, and leading small projects. Responsibilities include planning development batches, performing analyses, authoring batch records, and ensuring CAPAs are effective.
The Supply Chain Manager will lead process improvement projects across the supply chain, focusing on inventory management, production scheduling, and enhancing efficiency. The role involves utilizing Lean and Six Sigma methodologies, collaborating with cross-functional teams, and fostering a culture of continuous improvement.
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