What are the responsibilities and job description for the Associate, GxP Calibration and Maintenance position at Artiva Biotherapeutics?
About Artiva:
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.
Job Summary
The Calibration and Maintenance Associate plays a key role in overseeing maintenance and calibration activities, ensuring assets remain compliant with cGMP standards. The technician will be responsible for maintaining, repairing, and ensuring the availability of equipment in line with applicable standards.
Responsibilities
Why you should apply:
We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.
In addition to a great culture, we offer:
Base Salary: $75,000 - $85,000. Exact compensation may vary based on skills and experience.
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.
Job Summary
The Calibration and Maintenance Associate plays a key role in overseeing maintenance and calibration activities, ensuring assets remain compliant with cGMP standards. The technician will be responsible for maintaining, repairing, and ensuring the availability of equipment in line with applicable standards.
Responsibilities
- Organize calibration and Preventive Maintenance (PM) schedules in coordination with internal customers and vendors, ensuring clear communication and alignment.
- Assist in the identification and remediation of any issues related to system calibration or PM compliance.
- Serve as the calibration administrator on instrument calibration tracking software.
- Administer the computerized maintenance management system (CMMS) with a focus on asset acquisition, calibration, and preventive maintenance.
- Review data loading into CMMS and managing workflow for data changes.
- Create purchase orders for services rendered, and direct invoices and credits to proper accounts.
- Write and update Equipment Operation, and Maintenance of SOPs.
- Maintain good documentation practices in line with regulatory requirements.
- Support a safety-first, quality-always maintenance team.
- Support equipment onboarding activities, including but not limited to, initial asset entry, calibrations, and validations.
- Support site instrumentation and system change controls.
- Assist with the coordination of validation protocol execution, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with cross-functional teams to define validation strategies and establish documentation standards.
- Demonstrate strong understanding of GMP practices and guidelines.
- Proficient in using Microsoft Office tools.
- Develop and update Standard Operating Procedures (SOPs) for equipment operation and maintenance.
- Maintain good documentation practices in line with regulatory requirements.
- B.S. or H.S. diploma with trade school and/or formal training on equipment and instrument calibration.
- Two years of metrology experience.
- Experience with Computerized Asset Management System.
- Proficiency of Windows, including Outlook and Excel.
- Experience working in a GMP environment.
- Previous experiences in the pharmaceutical, medical devices, and biotechnology industries are preferred.
- Working knowledge of cGMP and ISO standards.
- Ability to gown and exhibit proper cleanroom behavior.
- Perform preventive and corrective maintenance and calibration on Process Instrumentation, Temperature, Pressure, Flow and Automatic Control Valves
- Troubleshoot and diagnose process instrumentation equipment problems and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of process instrumentation.
- Ability to read P & ID drawings and schematics.
- Highly attention to details, especially in GMP documentation.
- GMP experience
- Ability to use Microsoft Office tools.
Why you should apply:
We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.
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: $75,000 - $85,000. Exact compensation may vary based on skills and experience.
Salary : $75,000 - $85,000
