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Manager, GxP Validation, Calibration and Engineering

Artiva Biotherapeutics

Artiva Biotherapeutics

San Diego, CA, USA
Posted on Thursday, March 28, 2024

About Artiva

Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

Job Summary

The Manager, GxP Validation, Calibration, and Engineering, is responsible for developing the Validation and Calibration functions at Artiva, which include managing consultants and contractors to support operation activities such as facility buildouts and commissioning, qualification and validation of equipment and systems to support GxP operations. The incumbent is also responsible for developing and managing equipment history files for GxP equipment, which encompasses initial qualification, calibration, maintenance, and re-qualification throughout the equipment and systems lifecycle.

Responsibilities

  • Lead the day-to-day activities of the calibration and validation program by developing relevant functional procedures, program structure, deliverables, dashboards, monitoring, and reporting.
  • Lead the validation program by developing, reviewing, and approving validation lifecycle documents for facility commissioning as specified in the validation master plan and internal SOPs (e.g. Validation Plans, Protocols and Reports, URS, Technical Specifications)
  • Source and implement an electronic CAL/PM program for management of GxP equipment. May require sourcing of regulated software.
  • Oversee outsourced calibration and certification activities.
  • Coordinate activities related to the GMP space.
  • Initiates deviations, conducts investigations and impact assessments, proposes action plans, change controls and to address GxP Validation, Calibration and Engineering
  • Develop risk assessments, FMEA to support commercialization.
  • CMC support of regulatory filings.
  • Ensure adherence to all relevant regulatory requirements, Validation Master Plan and internal procedural requirements.
  • Maintain a safe work environment; work in a safe manner, following all safety SOP’s and wear Personal Protective Equipment as required.
  • Act as the point person for the facilities & equipment technicians while working closely with management to ensure strategic planning, implementation of plans, resolving problems, while maintaining production quality.
  • Assist with bids for GMP facility work to be completed. Assist with the negotiation of vendor contracts. Oversee and schedule all vendor mechanical equipment systems work and contractor services.
  • Manage external service providers, ensuring that deliverables are met in a timely manner and within budget. Monitors and maintains the contractor’s performance and works closely with outside vendors to ensure work is completed according to specifications.
  • Ensures clean rooms and general facility are maintained in optimum condition and in compliance with GMP requirements (e.g. owning the calibration program)
  • Routinely survey and evaluate necessary maintenance to the facility and facilitate maintenance, testing, troubleshooting and repair on systems while maintaining proper records.
  • Observe and trend facility issues for continuity and improvement.
  • Provide internal consulting support to reduce variability and improve efficiency as needed.
  • Maintain accurate records keeping equipment and systems cGMP compliant at all times. Ensures maintenance work orders are being completed on time while adhering to operational standards. Maintain and organize spare parts and consumables.
  • In partnership with management, ensure compliance with all applicable regulatory agencies, including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
  • Oversee construction and equipment installation, and preventative maintenance, related to the GMP areas.
  • Assist in project completion and may provide recommendations and solutions to technical problems and facility issues.

Qualifications

  • Bachelor’s degree or higher in Engineering, Life Sciences, or related field.
  • Extensive experience (typically 8+ years) in calibration and validation within a GMP-regulated industry, with progressive leadership responsibilities.
  • In-depth knowledge of GMP regulations and guidelines (e.g. FDA 21 CFR Part 210/211, EU GMP Annex 15).
  • Strong technical experience in calibration principles, validation methodologies, and risk-based approaches.
  • Strong leadership and cross-functional collaboration to drive change.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Detail-oriented with a focus on quality, compliance, and continuous improvement.
  • Proven ability to meet tight timelines, multi-task, and prioritize workloads.

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 cancer 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.

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

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $125,000 - 150,000 . Exact compensation may vary based on skills and experience.