Senior Manager, Quality Control- Microbiology

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 Senior Manager, Quality Control Microbiology role provides QC-Micro leadership for Immunity Bio’s early phase (phase I/II) clinical and commercial manufacturing operations, Contract Manufacturing Organizations, and Contract Testing Laboratories. This role is responsible for overseeing all GMP QC Microbiology activities supporting clinical and commercial manufacturing operations which includes maintenance of QC Micro sections for global regulatory applications, as well as regulatory support functions for inspections or information requests.  Specific areas of responsibility include, but are not limited to, design and oversee: the environmental monitoring program (EM), the personnel monitoring program (PM), all in-process and release testing (microbiology), all raw materials testing (microbiology), method establishment of microbiological assays, aseptic processing training program, utilities testing program (microbiology), facilities qualification (EMPQ), and cleaning validations. This position interacts cross-functionally with the Manufacturing, Facilities, Engineering, Regulatory, and Quality Assurance groups to ensure that all manufacturing areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.

Essential Functions

• Lead and plan all microbiology testing and monitoring activities in support of manufacturing operations across all early phase clinical manufacturing locations (for all ImmunityBio product platforms). Specific duties include:
• Design and oversee Environmental Monitoring programs including Facilities Qualification (EMPQ)
• Design and oversee Utilities Monitoring programs including critical utilities qualification programs
• Design and maintain Aseptic Process Simulation (Media Fill) Program
• Lead the execution of Disinfectant Efficacy studies to support Manufacturing Cleaning Program
• Support the advancement of the Contamination Control Program at in alignment with regulatory expectation and industry best practices
• Oversee method establishment for all Microbiology assays 
• Responsible for all microbiology and sterility control data review and authorization for external CMOs and CTLs
• Responsible for ensuring the integrity of all data including QC Microbiology assays in support of Stability Programs
• Review data from external partners pertaining to programs manufactured and tested outside of ImmunityBio
• Provide oversight of Quality System records for the QCM Department (Change Controls, CAPAs, Deviations, Lab Investigations, and Continuous Improvement)
• Investigative Microbial Data Deviations and invalid laboratory test results
• Provide technical expertise to address all microbial excursions (alert and action limits)
• Act as site Subject Matter Expert on Microbiology testing, method and process validation, and regulatory compliance requirements
• Ensure timely escalation of all facilities (internal and external), utilities and product related microbial issues
• Ensure QC Microbiology decisions align with Quality System, GMP and regulatory requirements
• Oversee the performance of designated team members, including interviewing, hiring and training employees, planning, assigning and directing work; coaching, mentoring, and  conducting performance reviews.
• Track and trend all facility, utilities, personnel, and product related microbiology data (across all product platforms)
• Provide support and maintenance for all assigned regulatory applications including IND, BLA, and other global documents
• Maintain Microbiology Laboratory in a state of control, compliance, and inspection readiness
• Interface with all auditors (internal and external) to ensure positive audit outcomes
• Interface with other departments (e.g., Manufacturing, Facilities, Engineering, QA and Regulatory) to ensure achievement of ImmunityBio’s goals
• Perform and delegate  other Quality Control related duties, as assigned

Education & Experience

• Bachelor’s degree in microbiology or biology, with a minimum of10+ years of microbiology/sterility control required; or
• Master’s degree in microbiology or biology, with a minimum of 8+ years of microbiology/sterility control required.
• 7+ years of management experience required
• Experience qualifying GMP manufacturing facilities (EMPQ, utilities qualification and validation) required
• Experience managing Contract Testing Laboratories required
• Experience hiring, training, and leading cross-functional teams required
• Experience in aseptic manufacturing operations within a GMP regulated Biologics or Pharmaceutical environment required

• Experience with a start-up pharmaceutical company preferred.
• Experience with the simultaneous management of multiple products through early phase clinical trials preferred

Knowledge, Skills, & Abilities

• Deep knowledge of microbiology, aseptic processing, and facilities control (environmental monitoring, personnel monitoring, utilities monitoring).
• Proficiency with statistical analysis software (SAS, JMP, PRISM, excel etc.).
• Ability to present data to teams and coordinate activities
• Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
• Strong problem-solving skills with demonstrated attention to detail.
• Demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines.

Working Environment / Physical Environment

• This position will work on site in a lab environment
• Ability to gown and gain entry in to manufacturing areas
• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval
• Flexibility in working schedule, i.e., off hours, second shift, and weekends
• Routine travel up to 25% to California facilities. Additional travel may be required to support audits.

• Ability to lift up to 50 pounds on occasion

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.

$157,500 (entry-level qualifications) to $175,000 (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.