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Manager, Facilities

Manager, Facilities

ImmunityBioSan Diego, CA, United States
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Company Overview

ImmunityBio, Inc. (NASDAQ : IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal : to reprogram the patient's immune system and treat the host rather than just the disease.

Why ImmunityBio?

  • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
  • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
  • Work with a collaborative team with the ability to work across different areas of the company.
  • Ability to join a growing company with professional development opportunities.

Position Summary

The Manager, Facilities is responsible for overseeing and maintaining the Process and Analytical Development Lab and GMP QC equipment and plant utility systems including, air compressors, heating, ventilating and air conditioning systems (HVAC), Deionized Water System, primary and secondary power distribution and the physical plant. This role will implement improvements to improve efficiency and prevent equipment obsolescence and ensure the validated state of equipment, systems and facilities and compliance with all applicable cGMP, OSHA, EPA and local government regulations. The manager will mentor and manage the daily activities of a technician as well as all facilities vendors and contractors on site.

Essential Functions

  • Responsible for maintaining all R&D and QC GMP equipment and plant utility systems including vacuum pumps, air compressors, heating, ventilating and air conditioning systems (HVAC), Deionized Water, emergency generator and primary and secondary power distribution.
  • Responsible for developing and managing the daily activities of the facility technician during all phases of maintenance and facilities modification. This includes ensuring the technician can effectively and efficiently meet the needs of the organization in a manner consistent with the company mission and values and other standards of conduct.
  • Implements improvements to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects like installing Bioreactors, Chillers and Centrifuges, CTUs, and analytical equipment.
  • Ensures the IQ, OQ, PQ, CAL and PM state of all equipment, and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations.
  • Performs, assists and oversees preventive maintenance of site equipment on a regular basis, manage initial troubleshooting, perform minor repairs as needed.
  • Manage equipment records including IQ / OQ / PQ reports. Serve as point of contact t for vendors for instruments maintenance / repair.
  • Responsible for site process gas (CO2, CCA, LN2, O2, N2) requirements. This assignment includes managing the weekly monitoring of gas usage, gas ordering, gas receiving and replacement
  • Obtains and negotiates vendor quotes and purchase orders covering the physical plant, equipment preventive maintenance, calibration and qualification / validation. This includes management, inducting and adding service reports to Blue Mountain Regulatory Asset Manager (BMRAM).
  • Prepare metrics reports for facilities calibrations and metrology KPI.
  • Lead engineering projects including but not limited to equipment installation, commissioning, and validation process. Ability to assist within the engineering group in equipment failure root cause analysis with prompt resolution.
  • Creates, maintains and adheres to Standard Operational Procedures (SOP), work plans, maintenance data templates, and drawing redlines as necessary.
  • Maintains documents in VEEVA.
  • Responsible for the general upkeep of the physical plant including offices, laboratories and parking garage.
  • Leads and attends required training and meetings.
  • Leads and participates in audits and regulatory inspections.
  • Serves as incident commander for the site.
  • Ensure compliance and managing interactions with all applicable regulatory agencies including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
  • Responsible 24 / 7 to resolve emergency calls relating to Building Management System (Metasys), Environmental Chambers (Rees) and site Security.
  • Performs other special projects and duties as requested.
  • Education & Experience

  • Bachelor's Degree with 8+ years' progressive experience in a relevant field required; or
  • High school Diploma with 12+ years of progressive experience in a relevant field required.
  • 5+ years' experience working in an FDA regulated environment required.
  • Experience with and working knowledge of facilities equipment and preventive maintenance programs required.
  • Experience with and working knowledge of Computerized Maintenance Management Systems (CMMS) required
  • Experience with process and analytical equipment is highly preferred.
  • Experience in a Pharma-Biotech manufacturing environment is preferred.
  • Knowledge, Skills, & Abilities

  • Self-starter with the ability to work independently
  • Excellent Instrumentation and mechanical skills and knowledge of maintenance principles.
  • Ability to work in a fast-paced environment and maintain a high level of customer service.
  • Hands-on execution of maintenance of process equipment, utility equipment, and facilities
  • Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, automated pharmaceutical processing and plant equipment.
  • Knowledge of and ability to comply with EPA, OSHA, and NFPA regulations and with SOPs and cGMP policies.
  • Ability to troubleshoot, diagnose, and repair critical equipment.
  • Knowledge of high and low voltage distribution.
  • Knowledge of plant utility systems.
  • Excellent written and verbal communication skills to effectively convey information in face-to-face and in group settings
  • Excellent teamwork and cooperation skills.
  • Ability to understand and comprehend oral and written instructions
  • Understanding of analytical troubleshooting.
  • Excellent leadership and mentoring skills.
  • Ability to lead and navigate others through complex situations.
  • Able to work independently and make sound judgments regarding safety, work methods and tools
  • Proficient at understanding and writing reports and work instructions.
  • Working Environment / Physical Environment

  • This position works on-site.
  • Exposure to onsite in-lab environment.
  • Must be able to don and wear Personal Protective Equipment (PPE) as required.
  • Available to work off hours (weekends, holidays, after hours) to support company objectives.
  • Ability to work in a standing position for long periods of time (up to 8 hours).
  • Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position.
  • Must be able to operate a fork lift and pallet jack to aid in equipment relocation.
  • Must be able to frequently lift up to 35 pounds and occasionally lift / move 50 pounds.
  • This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

    $139,500 (entry-level qualifications) to $155,000 (highly experienced) annually

    The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

    ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include : Medical, Dental and Vision Plan Options

  • Health and Financial Wellness Programs
  • Employer Assistance Program (EAP)
  • Company Paid and Voluntary Life / AD&D, Short-Term and Long-Term Disability
  • Healthcare and Dependent Care Flexible Spending Accounts
  • 401(k) Retirement Plan with Company Match
  • 529 Education Savings Program
  • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  • Paid Time Off (PTO) includes : 11 Holidays
  • Exempt Employees are eligible for Unlimited PTO
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
  • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
  • At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and / or expression, or other status protected by law.

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    Manager • San Diego, CA, United States

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