Director, Commercial QCA
2 months ago
Culver City
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 Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials and finished products related to the commercial N-803 program and all other QCA programs that are advancing to the commercial stage.. Essential Functions • Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability)., • Transfer, review, and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies., • Ownership and oversight of all assay trending programs, • Design and implement methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability. Design and implement strategies to transfer methods into QCA groups., • Ensure QCA decisions align with Quality System, GMP and regulatory requirements., • Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation., • Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance., • Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems., • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in biology, chemistry, or other scientific related field with 15 years of related quality experience with 8+ years at the management level required; or, • Master's degree in biology, chemistry, or other scientific related field with 10 years of related quality experience with 8+ years at the management level required; or, • Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience with 8+ years at the management level required, • Extensive experience with assay qualification, validation, and transfer activities required, • Experience for a FDA PLI, Surveillance, or other inspection, with an acceptable outcome required, • Experience with a start-up pharmaceutical company preferred Knowledge, Skills, & Abilities • Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques. Understanding of cell therapy processes is desirable, • Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections, • Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously, • Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities, • In-depth knowledge in analytical method development and validation, and statistical quality control., • In-depth knowledge of GMPs, SOPs and pharmaceutical regulations., • Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action., • Understanding of GMPs and an ability to interpret and enforce regulatory requirements., • Ability to communicate professionally, knowledgeably, and efficiently with a wide range of employees and with all internal and external customers, both in writing and verbally., • Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems., • Ability to define problems, collect data, establish facts and draw valid conclusions., • Demonstrated track record in managing a staff and establishing a clear, strategic direction., • Ability to develop a high-morale organization with leaders, teams, and groups, and appropriately staff the QC department to meet business needs., • Ability to analyze and interpret complex, scientific documents, including problem solving., • Ability to multi-task and prioritize with excellent project management skills. Working Environment / Physical Environment • This role will work on site, • Flexibility in working schedule, i.e., off-hours, second shift and weekends as needed, • Performs work in the lab as needed to supervisor staff and oversee quality control programs, • Must be able to gown PPE as needed to enter lab settings 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 as well as geographic location. $215,000 (entry-level qualifications) to $236,500 (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.
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