Associate, Quality Control – Cell Culture

ImmunityBio, Inc.•San Diego, CA

1d•$32 - $35•Onsite

About The Position

The Associate, Quality Control - Cell Culture is responsible for ensuring the timely execution of Quality Control Analytical assays in support of product release across all of Immunity Bio’s oncology and vaccine product platforms. This position requires expertise with cell culture and cell based assays. This role will interact cross-functionally with members of the Manufacturing, Quality Assurance, Analytical Development, and Process Sciences teams.

Requirements

Bachelor’s degree in a life sciences discipline with 1+ years of relevant experience required
Experience and knowledge of analytical cell-based assays preferred
Experience with the technical transfer and qualification/validation of analytical assays preferred
Fundamental knowledge of cell and molecular biology, and immunology.
Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
Strong problem-solving skills with demonstrated attention to detail.
A demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines.

Responsibilities

Ensure and support a safe working environment for work areas.
Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements.
Participate in method qualification, validation and transfer activities.
Support instrument installation and operational qualification activities (IOQ).
Ensure a compliant work space by adhering to and enforcing GxP requirements.
Support and/or lead out of specification and out of trend investigations and implement corrective actions as needed to prevent reoccurrence.
Approve testing performed by other team members to ensure timely release of test data.
Ensuring the integrity of all data generated.
Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance.
Ensure timely escalation of all assay related challenges/issues and assist in developing countermeasures to improve performance.
Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
Participate and/or lead continuous improvement activities to help improve the overall operations of the testing labs.
Maintain analytical laboratory in a state of control, compliance, and inspection readiness.
Interface with all auditors (internal and external) to ensure positive audit outcomes.
Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
Adhere to and contribute to creating Standard Operating Procedures (SOPs) and process improvements.
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