Specialist, Quality Control Analytical

Job description

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 Specialist, Quality Control Analytical will serve as Subject Matter to advise 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. Issue ImmunityBio release Certificates of Analysis (CoAs) to support QA lot disposition activities. 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 Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree with 6+ years relevant experience in Analytical Chemistry or related discipline required; or Master's degree with 4+ 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 and computer skills. Working Environment / Physical Environment This position works on-site. 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. Exposure to onsite in-lab environment. Must be able to don and wear Personal Protective Equipment (PPE) as required. Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Must be able to lift frequently lift up to 35 pounds and occasionally lift/move 50 pounds. This position is eligible for a discretionary bonus and equity award. The hourly 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. $42.85 (entry-level qualifications) to $47.12 (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.