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Senior Manager, Quality Control Microbiology Specialist

1 month ago

El Segundo, California, United States ImmunityBio Full time
Job Title: Senior Manager, Quality Control Microbiology

At ImmunityBio, we are seeking a highly experienced Senior Manager, Quality Control Microbiology to lead our Quality Control Microbiology team. This role will be responsible for overseeing all GMP QC Microbiology activities supporting clinical and commercial manufacturing operations.

Key Responsibilities:
  • 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
  • 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)
  • Investigate 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
  • Develop and mentor QC Microbiology team members
  • Track and trend all facility, utilities, personnel, and product-related microbiology data (across all product platforms)
  • 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
  • Oversee the performance of designated staff, including interviewing, hiring, and training employees, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints, and resolving problems
  • Conduct other Quality Control-related duties, as assigned
Requirements:
  • Bachelor's degree in microbiology or biology, with a minimum of 8-10 years of microbiology/sterility control at the management level; or
  • Master's Degree is preferred in microbiology or biology, with a minimum of 6-8 years of microbiology/sterility control at the management level
  • Experience in aseptic manufacturing operations within a GMP-regulated Biologics or Pharmaceutical environment
  • Experience with a start-up pharmaceutical company preferred
Knowledge, Skills, and Abilities:
  • Deep knowledge of microbiology, aseptic processing, and facilities control (environmental monitoring, personnel monitoring, utilities monitoring)
  • Experience with the simultaneous management of multiple products through early phase clinical trials
  • Experience qualifying GMP manufacturing facilities (EMPQ, utilities qualification, and validation)
  • Experience hiring, training, and leading cross-functional teams
  • Experience managing Contract Testing Laboratories
  • Strong technical writing skills with experience preparing SOPs, analytical test reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings
  • Experience with statistical analysis software (SAS, JMP, PRISM, Excel, etc.)
  • 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
  • Exposure to onsite in-lab environment
  • Ability to gown and gain entry into manufacturing areas
  • 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, and geographic location.

$160,000 (entry-level qualifications) to $170,000 (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.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation, we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.