Senior Manager, MSAT

About the Company

Artiva is a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com.

About the Role

As a member of the MSAT (Manufacturing Science & Technology) organization, you are a key player in the MSAT team supporting Artiva’s allogeneic manufacturing processes. The Sr. Manager, MSAT Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial manufacturing.

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records, SOPs, deviation reports, and technical risk assessments with a strong understanding of equipment, process, and testing.
• Leads deviations process under QA supervision and performs thorough Root Cause Analysis.
• Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Authors manufacturing investigations and drives CAPA implementation.
• Supports raw materials characterization and E&L risk assessment.
• Creates dashboards to visualize manufacturing data.
• Establishes Track and Trend program in collaboration with biostatistics.
• Performs other duties as assigned.

Requirements

• Bachelor’s, Master’s, or PhD degree in biotechnology, chemical engineering, or related disciplines.
• Proven experience in 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, as well as 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.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Group life insurance.
• Long-term disability (LTD).
• 401(k) retirement plan.
• Employee Assistance Program (EAP).
• Flexible Spending Account (FSA).
• Paid Time Off (PTO).
• Company-paid holidays, including the year-end holiday week.
• Recognition program (Bonus.ly) where points earned can be traded for rewards.

A beautiful facility and an entrepreneurial, highly collaborative, and innovative environment.

Pay

Base Salary: $150,000 - $165,000. Exact compensation may vary based on level, skills, and experience.