Senior Manager, MSAT

artivabio; San Diego (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Medical

Dental and Vision

401(k) Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Company paid holidays

Job summary

Artiva is seeking a Sr. Manager, MSAT Engineer to lead tech transfer and process validation for late-stage clinical and commercial manufacturing.

You will drive documentation, troubleshooting, investigations and CAPA in a fast-paced, regulated environment. You have advanced degrees in biotech or chemical engineering, strong project management skills, and hands-on experience with cGMP, IQ/OQ/PQ, and aseptic processing.

Qualifications

• Bachelor’s, Master’s or PhD in biotech or chemical engineering.
• Experience managing complex projects in pharma/biotech.
• Technical depth in late-stage clinical and commercial manufacturing.
• Ability to establish business processes and governance.
• Strong interpersonal and communication skills.
• Cell culture, cell therapy or aseptic processing experience.
• Experience with IQ/OQ/PQ and process validation in cGMP.
• Proactive and adaptable with willingness to take on temporary duties.

Responsibilities

• Support tech transfer and validation for manufacturing projects.
• Write Master Batch Records, SOPs, deviations, and risk assessments.
• Lead deviations with QA and perform root cause analysis.
• Monitor production for process issues and troubleshoot.
• Author investigations and drive CAPA.
• Support raw materials characterization and risk assessment.
• Create dashboards to visualize manufacturing data.
• Establish Track and Trend program with biostatistics.
• Other duties as assigned.

Skills

Project management

Process engineering

cGMP knowledge

Root cause analysis

Documentation

Communication skills

Cell culture experience

IQ/OQ/PQ

Regulated engineering

Education

Bachelor’s/Master’s/PhD in biotechnology or chemical engineering

Job description

About Artiva: We are 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.

Job Summary

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 responsibilities include 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.

Duties/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.

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.

In addition to a great culture, we offer:

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:

• Medical, Dental, and Vision
• 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
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

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