Senior Manager, MSAT

Artiva Biotherapeutics•San Diego, CA

8d•Onsite

About The Position

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, create an opportunity to generate potentially transformative therapies. As Senior Manager, MSAT Engineer, you’ll provide hands-on technical leadership across clinical and commercial manufacturing, driving tech transfer, process validation, troubleshooting, investigations, and manufacturing excellence in a fast-paced, growing biotech. 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.

Requirements

Bachelor’s, Master’s, or PhD degree in biotechnology, chemical engineering, or related disciplines.
Proven experience in managing complex projects.
Technical depth & 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.

Responsibilities

Performing tech transfers of new processes and technologies into the site.
Preparation of documentation to support process validation and batch manufacturing.
Troubleshooting manufacturing processes.
Completing process deviations and investigations.
Tracking and trending manufacturing data.
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 the 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.
Establishes a Track and Trend program in collaboration with biostatistics.