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Salary: USD 150,000 - 165,000 / annual
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 for use in community settings.
As Senior Manager, Manufacturing Science & Technology (MSAT) Engineer, you will provide hands-on technical leadership across clinical and commercial manufacturing operations. You will be a key player in the MSAT team supporting Artiva's allogeneic manufacturing processes in a fast-paced, growing biotech environment.
Key responsibilities include:
- Provide technical assistance for process tech transfer and validation efforts for assigned manufacturing projects
- Write Master Batch Records, SOPs, deviation reports, and technical risk assessments with deep understanding of equipment, process, and testing
- Lead the deviations process under QA supervision and perform thorough Root Cause Analysis
- Monitor manufacturing processes during production runs to assess technical issues and provide troubleshooting support
- Author manufacturing investigations and drive CAPA (Corrective and Preventive Action) implementation
- Support raw materials characterization and E&L risk assessment
- Create dashboards to visualize manufacturing data
- Establish a Track and Trend program in collaboration with biostatistics
- Execute all functions following standard operating procedures, batch records, and in accordance with FDA and EU requirements and current Good Manufacturing Practices (cGMP)
You will work in a collaborative, innovative environment with a beautiful facility and entrepreneurial culture.
REQUIREMENTS:
- Bachelor's, Master's, or PhD degree in biotechnology, chemical engineering, or related disciplines
- Proven experience managing complex projects
- Technical depth and process expertise in late-stage clinical and commercial manufacturing
- Ability to establish business processes, drive standardization, and governance in complex environments
- Excellent interpersonal, verbal, and written communication skills; presentation skills; and digital literacy
- Cell culture, cell therapy, or aseptic processing experience
- Equipment and/or new technology design, qualification, and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
- Strong understanding of GMP environment and change control processes
- Experience with investigations and structured problem-solving methodologies (e.g., deviations, DMAIC, root cause analysis)
- Proactive and willing to accept temporary responsibilities outside of initial job description
- Experience in engineering in highly regulated manufacturing environments
