Senior Specialist, Quality Control Analytical
About The Position
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. 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.
Requirements
- 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.
- 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
Nice To Haves
- Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development is preferred.
Responsibilities
- 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.
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
