Senior Manager, MSAT

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Beautiful facility

Collaborative culture

Comprehensive benefits

Job summary

Artiva Biotherapeutics Inc. is seeking a Sr. Manager, MSAT Engineer to lead tech transfer, validation and investigations for complex NK cell manufacturing. You will write MBRs and SOPs, drive deviation handling and CAPA, and monitor processes to ensure GMP compliance.

You will collaborate across QA, manufacturing and biostatistics to develop Track and Trend programs, characterize materials, and support ongoing process improvements in a fast-paced, regulated environment.

Qualifications

• Bachelor’s, Master’s or PhD in biotechnology, chemical engineering or related disciplines.
• 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.

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.
• 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 data.
• Establish Track and Trend program in collaboration with biostatistics.
• Other duties as assigned.

Skills

Project management

cGMP manufacturing

Process validation

Root cause analysis

Deviation investigations

Quality systems

Cross-functional collaboration

Documentation (MBR/SOPs)

Cell culture / cell therapy

Regulatory compliance

Education

Biotech / Chemical Eng PhD/Master/Bachelors

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 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.

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 visualiz e m anufacturing


• 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.

If all this speaks to you, come join us on our journey!

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