Senior Manager, Quality Control Microbiology

ImmunityBio, Inc.•El Segundo, CA

3d•Onsite

About The Position

The Senior Manager, Quality Control Microbiology role provides QC-Micro leadership for ImmunityBio’s early phase (phase I/II) clinical and commercial manufacturing operations at our El Segundo, California, Contract Manufacturing Organizations, Contract Testing Laboratories, and other external collaborators. The Senior Manager for QC-Micro is responsible for overseeing GMP QC Microbiology activities for alliance partner programs supporting clinical and commercial manufacturing operations. This position is responsible for strategic ownership of the Contamination Control Program at the site(s) in alignment with regulatory expectations and industry best practices with specific areas of responsibility to include, but are not limited to, the governance over CCS element of 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.

Requirements

Bachelor’s degree in microbiology or biology, with a minimum of 8+ years of microbiology/sterility control at the management level required; or Master’s Degree in microbiology or biology, with a minimum of 5+ years of microbiology/sterility control at the management level required
Experience in aseptic manufacturing operations within a GMP regulated Biologics or Pharmaceutical environment required
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 tests 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.
This position will work on site.
Exposure to onsite in-lab environment.
Ability to gown and gain entry in to 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.

Nice To Haves

Experience with a start-up pharmaceutical company is preferred

Responsibilities

Establish, maintain, and oversee support to the contamination control programs for both internal and partner sites.
Design and oversee Environmental Monitoring programs including Facilities Qualification (EMPQ).
Design and oversee Utilities Monitoring programs including critical utilities qualification programs.
Coordinate the execution of Disinfectant Efficacy studies to support Manufacturing Cleaning Program.
Drive the advancement of the Contamination Control Program in alignment with regulatory expectations and industry best practices.
Design and maintain Aseptic Process Simulation (Media Fill) Program.
Oversee external microbiological testing.
Standardize and approve methods for raw‑material, in‑process, utility and finished‑product testing (bioburden, sterility, endotoxin, particulate, identification, etc.).
Review trend reports and data‑integrity checks.
Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, and developing and mentoring QC Microbiology teams.
Responsible for microbiology and sterility control data review and authorization for external CMOs and CTLs.
Verify that partner data (batch records, test results, validation reports) meet the company’s data‑integrity standards.
Lead or approve investigations of microbiology‑related deviations, OOS results and EM excursions.
Provide subject matter expertise 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.
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 Immunity Bio’s goals.
Create, edit and adhere to Standard Operating Procedures (SOPs).
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Benefits

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
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