Senior Manager, MSAT

Artiva Biotherapeutics•San Diego, CA

13d•Onsite

About The Position

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. The Sr. Manager, MSAT Engineer’s responsibilities include but are not limited to the following: 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, and track and trending manufacturing data. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

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

Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
Writes Master Batch Records, SOPs, deviation reports and technical risk assessment with a strong understanding of equipment, process and testing.
Lead 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.
Author manufacturing investigations and drives CAPA implementation.
Support raw materials characterization and E&L risk assessment.
Creates dashboard to visualize manufacturing.
Other duties as assigned.
Establish Track and Trend program in collaboration with biostatistics.