IB Temporary Specialist, QC Analytical

SA ImmunityBio LLC • Any • Utah, United States • 10h ago

Company Overview

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patients 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 patients 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 IB Temporary - Specialist, QC Analytical will serve as Subject Matter to advise contract testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.

Essential Functions

Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)

Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysis

Author and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable

Author, review and revise Analytical Section of documents such as the IND, BLA for regulatory CMC submission

Provide technical expertise to troubleshoot analytical methods

Mange suppliers change notifications and change controls

Generate Purchase Requests and Purchase Orders for contract testing laboratories projects

Ensure timely escalation of quality control related issues

Assist QC-Analytical management in tracking and trending data

Collaborate with other departments (e.g. QA and Regulatory) for quality control related duties

Attend QC-Analytical internal meetings and external meetings with contract testing laboratories

May conduct other duties, as assigned

Education & Experience

Bachelor's degree with 8+ years relevant experience in Analytical Chemistry or related discipline required; or

Master's degree with 6+ years of experience in Analytical Chemistry or related discipline required.

Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development required

Knowledge, Skills, & Abilities

Strong knowledge of quality control analytical method development, method validation and method transfer

Strong technical writing skills to author SOPs, analytical tests methods, qualification/validation protocols/ reports

Knowledge and understanding of USP, EP and ICH guidelines

In-depth knowledge of GMPs and pharmaceutical regulations

Ability to communicate effectively with internal functions both in writing and verbally

Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures

Ability to multi-task and prioritize

Strong problem solving

Strong computer skills

Working Environment / Physical Environment

This position will work on hybrid (combination on site and remote) in El Segundo, CA

Regular work schedule is Monday Friday, within standard business hours. Flexibility is available with manager approval.

The specific rate will depend on the successful candidates qualifications, prior experience as well as geographic location.

$44.69 (entry-level qualifications) to $49.65 (highly experienced) per hour

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.

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