Specialist, Quality Control Stability & Reference

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

POSITION SUMMARY

The Specialist will perform activities to support the ImmunityBio stability and reference programs including activity scheduling (Internal and Contract Labs) and tracking, data trending, statistical analysis, investigations, inventory management, equipment control and maintenance activities, protocol and report drafting, sample processing (sample receipt, logging, and shipping) and Contract Request Forms and PR submissions.

Important aspects of this role include report writing abilities, familiarity with stability and reference requirements, excellent organization skills, independent performance, flexibility, and the ability to thrive in an efficient, highly interactive, goal oriented team environment.

ESSENTIAL FUNCTIONS

• Stability coordination activities (e.g. stability sample shipping, data entering, data trending, protocol and report drafting, data presenting).
• Reference Standard Activities (e.g. reference standard qualification and requalification protocol and report drafting, reference standard inventory managing, reference standard shipping)
• Budgetary Work (e.g. Contract Request Form, Purchase Request and Purchase Order drafting, submitting and managing)
• Quality Systems and Documentation Support (e.g. Stability SOP, Reference Standard SOP, etc.)

EDUCATION/EXPERIENCE REQUIREMENTS

• > 4 years of relevant experience (or 2 years and a Masters Degree) in the Biotechnology industry with emphasis in quality control (QC) testing, stability, and reference standards.

REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• Communicational Influence
• Software Skills (MS Word, Excel, PowerPoint)
• People Skills
• Leadership Skills
• Writing Skills
• Time Management
• Knowledge of cGMP, FDA, and USP regulations and a solid understanding of statistics

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

• The ability to lift 25 pounds or less occasionally.
• The ability to assist with receiving and stocking supplies, equipment maintenance, and executing test assays.

*All hires are based upon completion and passage of a background check

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.