Position SummarySenior Specialist quality Control, experienced in various analytical methods (chromatographic and electrophoretic) will serve as Subject Matter Expert to lead and 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 and review 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
- Review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable
- Review and update Analytical Section of documents such as the IND, BLA for regulatory CMC submission
- Provide technical expertise to troubleshoot analytical methods
- Ensure timely escalation of quality control related issues
- Assist QC-Analytical management in tracking and trending data
- Create product Certificate of Analysis (CoA)
- Manage Supplier Change Notifications and Change Controls
- Generate Supplier Purchase requisitions and Purchase Orders
- 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
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Support internal audits and regulatory inspections
- 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 8+ years relevant experience is required; OR
- Master's degree with 6+ years of relevant experience is required.
- 6+ years of Analytical Chemistry or related discipline experience is required.
- Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development is preferred.
Knowledge, Skills, & Abilities- Strong knowledge of quality control analytical method development, method validation and method transfer
- Strong technical writing skills to author 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 works on site, as noted in the offer letter.
- Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
- Exposure to onsite lab environment.
- Flexibility in the working schedule may be required to complete work off-hours in order to complete deadlines.
- This position may require the ability to wear the appropriate PPE attire.
- Lift and carry materials weighing up to 20 pounds.
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.
$1115,000 (entry-level qualifications) to $128,000 (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 uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.
Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.
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.
