Director, Facilities, Engineering, Maintenance & EHS

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

This Director will be a strategic leader for facilities engineering, maintenance and environmental health and safety (EHS) teams and is responsible for the overall management of site operations inclusive of administration, general operations and services. The role will oversee the safety and maintenance of systems; and direct a team of engineers and specialists to collaborate with Manufacturing, Quality Assurance, Validation and several other departments. The Director will use expertise gained through prior experience to focus on specified areas of the business for business planning. 

Essential Functions

• Manage the necessary resources and suitable technology to complete projects in accordance with the safety, environmental, regulatory and business goals and standards.
• Mentor, coach, train engineers on engineering practices, policies and requirements to support GMP operations
• Evaluate costs, schedule impact, opportunities and risks when making decisions
• Prepare, maintain, and monitor budget and schedule.
• Manage high level projects that require internal oversight, including the development of project scope, timelines and implementation strategy, to ensure that manufacturing operations continue uninterrupted
• Responsible for implementing improvements to improve efficiency and prevent equipment obsolescence.  Included are capital improvement projects like installing HVAC, GMP and non-GMP equipment and systems
• Responsible for insuring the validated state of all equipment, systems and facilities and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations
• Provide daily oversight of facility EHS Programs including chemical hygiene and hazard communication, biosafety, Lockout tagout, fall protection, confined space, personal protective equipment, area inspections, fire code compliance, emergency response, haz-waste disposal, regulatory permitting, program development and implementation, EHS training, and EHS performance metrics. Ensure written programs are reviewed and updated as required
• Serve as a point of contact with Federal, State and local regulatory authorities and Partners with both internal and external Occupational Health resources on medical surveillance and consultation matters.
• Lead risk assessment evaluations to ensure the identification of high risks and associated risk reduction corrective actions.
• Lead bi-monthly site audits for all sites to encourage and enforce incremental improvement of safety and compliance. Develop and track metrics for these audits to gauge compliance and corrective actions.
• Author and review SOPs, protocols, change controls
• Direct engineering design reviews as needed
• Performs other duties as assigned

Education & Experience

• Bachelor’s degree in engineering or equivalent 
• 12+ years’ experience of relevant experience in Pharma/Biotech
• 7+ years’ management experience

Knowledge, Skills, & Abilities

• Must be familiar with high and low voltage distribution.
• Must be familiar with machine controls including Programmable Logic Controllers (PLC’s), relay logic, and operator interfaces.
• Must be familiar with plant utility systems including high-pressure steam, heating, ventilating and air conditioning (HVAC).
• Must have a clear understanding of schematics and diagrams
• Thorough understanding of GMP related to Facility design and operation, equipment, utility and cleanroom design, operation and maintenance.
• Knowledge of industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing and laboratories.
• Knowledge of engineering principles required to support GMP facilities and equipment
• Must have good written and verbal communication skills, good documentation skills, good organizational skills and good interpersonal skills to manage a diverse group of skilled technicians and engineers
• Experience with commissioning, IQ/OQ/PQs for GMP equipment and facilities
• Experience with and knowledge of related quality systems such as change control; CAPA (including deviations/OOSs); training and document control
• Working knowledge of GMP, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment
• Excellent communication and leadership skills
• Strong leadership/management skills
• Strong analytical and problem-solving skills
• Able to have flexible work schedules

Working Environment / Physical Environment

• This position works on-site in El Segundo, CA
• Ability to sit, stand, walk and lift 10 lbs.
• Required to walk 40% of the time, stand 20% of the time and sit 40% of the time.
• Travel for this position is required. Approximately 30% is typical

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.

$175,000 (entry-level qualifications) to $205,000 (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.