SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The company's lead product, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy designed to work in combination with monoclonal antibodies.
As Senior Manager of Manufacturing Science & Technology (MSAT), you will be a key technical leader supporting Artiva's allogeneic manufacturing processes. You will drive results in a fast-paced environment by providing technical expertise for both clinical and commercial manufacturing operations.
Key responsibilities include:
- Lead technology transfer of new processes and manufacturing methods into production sites
- Prepare comprehensive documentation for process validation and batch manufacturing in compliance with FDA and EU requirements
- Troubleshoot manufacturing process issues and provide real-time technical support during production runs
- Author and lead deviation investigations, root cause analyses, and corrective/preventive action (CAPA) implementation under QA supervision
- Write Master Batch Records, standard operating procedures, and technical risk assessments
- Support raw materials characterization and extractables & leachables (E&L) risk assessment
- Establish track-and-trend programs in collaboration with biostatistics to monitor manufacturing performance
- Create dashboards to visualize manufacturing data and trends
- Ensure all work follows standard operating procedures and batch records in accordance with cGMP standards
You will need a Bachelor's, Master's, or PhD in biotechnology, chemical engineering, or related discipline, with proven experience managing complex projects in late-stage clinical and commercial manufacturing. Cell culture, cell therapy, or aseptic processing experience is essential. You should have hands-on experience with equipment design, qualification, and testing in cGMP environments (IQ/OQ/PQ), process validation, and structured problem-solving methodologies. Strong understanding of GMP environments, change control processes, and excellent communication skills are required.
