The Associate Director will oversee all internal and outsourced Immunity Bio stability and reference standard program.  This includes (but is not limited to) oversight of the Stability and Reference team and performing activities including activity (time points, fills, testing, reporting) scheduling and tracking, data trending, data review meetings, statistical analysis, investigations, inventory control, and protocol and report drafting.  The position will also support cross-functional interactions with the Regulatory, Manufacturing, Quality Assurance, and Quality Control departments.

Essential Functions

• Manage all stability activities (testing forecasts, samples to labs, data from labs) for current and future programs.
• Manage all reference standard activities (fills, testing, characterization, report writing) for current and future programs.
• Manage traceability for all stability and reference materials, including completing and reviewing of logbooks.
• Manage activities such as data trending, time point forecasting, stability pulling, reference standard qualification and re-qualification for current and future programs.
• Provide budget for all Stability and Reference Activities
• Responsible for the oversight and completion of all Stability and Reference protocols and reports (interim and final reports).  Will participate in the drafting and review of these documents.
• Responsible for the completion of the Application (BLA/IND) sections and updates for Stability and Reference Sections.  Will be the primary author for these sections.
• Responsible to ensure all data review meetings are conducted either directly conducting them or overseeing staff to conduct them.
• Supervision and coordination of stability and reference staff, including staff development.
• Ensures all Quality Systems reports get completed on time, including (but not limited to) Change Controls, Deviations, CAPAs, and other support activities such as software implementation.
• Provide budget for all Stability and Reference Activities

Education & Experience

• Requires a Bachelor’s of Science degree in Biology or related discipline
• Requires 12+ years of relevant experience (or 10 years’ of experience and a Master’s Degree) in the Biotechnology industry with emphasis in GMP QC testing and/or stability support
• Demonstrated experience overseeing and supervising staff
• Experience with a GMP stability program, including working knowledge of how the program should function
• Experience participating in multiple programs simultaneously

Knowledge, Skills, & Abilities

• Experience with cGMP and GDP
• Solid understanding of statistics
• Understanding and ability to read and write stability reports, including required components, how to draft interim rand final reports.  Understanding of requirements for a reference standard qualification.
• Familiarity with Quality Systems such as change controls, deviations, and OOS
• Ability to present data to teams and coordinate activities
• Ability to lead teams, hire and mentor staff, and provide performance evaluations
• Ability to project manage and coordinate activities with good organizational skills

Working Environment / Physical Environment

• Ability to pack, ship, and receive stability and reference standards on site.
• The position will have a significant amount of desk work for the execution of the job description
• Flexibility in working schedule, may be required to complete work on off-hours in order to complete deadlines.
• May need to travel to different Los Angeles locations for support activities
• Position is an on-site position.

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

This position is eligible for a discretionary bonus and equity award.  The 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.

$155,000 (entry-level qualifications) to $170,000 (highly experienced)

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 15 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 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.