Scientist I, Process Sciences - Analytical Development
About The Position
The Scientist I, Process Sciences - Analytical Development will work alongside Process Sciences and Analytical Development (AD) team members to contribute to our efforts to develop and implement methods across ImmunityBio’s platforms, and the advancement of our pipeline by collaborating with internal and external partners. The role is responsible for method development and ensuring timely execution of samples in support of process development activities. The Scientist I, Process Sciences - Analytical Development will assist in data review, method qualification and/or validation, and training of junior team members.. The role will support AD management and Regulatory Affairs personnel with all regulatory filings and will require cross-functional interaction with members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams.
Requirements
- Bachelor’s degree in a scientific discipline with 10+ years of relevant experience in a GMP regulated Biologics or Pharmaceutical environment required; or Master’s degree n a scientific discipline with 8+ years of relevant experience in a GMP regulated Biologics or Pharmaceutical environment required.
- Experience in method development, method validation, and method transfer is required.
- Fundamental knowledge of analytical chemistry and chromatography is required.
- Ability to successfully interface with multidisciplinary teams
- Excellent verbal and written skills to communicate cross functionally
- Highly motivated, detail oriented and able to excel in a fast-moving environment.
- Knowledge of quality control analytical method development, method validation and method transfer
- Problem solving skills with attention to detail
- Knowledge and understanding of cGMP, 21 CFR 210/211, USP, EP and ICH guidelines
- In-depth knowledge of GMPs and pharmaceutical regulations
- Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures
- Ability to multi-task and prioritize
- Adept at instrumentation trouble shooting
- Strong statistical analysis skills
- Strong technical writing skills with experience preparing: SOPs, analytical test reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
Nice To Haves
- Fundamental knowledge of cell and molecular biology, immunology, and/or virology a plus.
Responsibilities
- Perform method development, optimization, and troubleshooting of analytical methods, for various product platforms with minimum supervision.
- Ensure the integrity of all data generated.
- Perform a variety of techniques to assess product quality and characterize products, including HPLC assays, UV-Vis and analytical chemistry techniques.
- Support efforts for method troubleshooting, remediation, change, and optimization efforts in conjunction with Quality Control and Analytical Development.
- Author and review analytical methods, SOPs, protocols, and reports.
- Support the Process Development teams to characterize process improvements and develop new products.
- Support internal and/or external transfers of analytical methods.
- Oversee the training and development of junior Analytical Development associates/specialists.
- Maintain, calibrate and operate analytical equipment and instruments.
- Provide technical expertise to troubleshoot assays.
- Ensure timely escalation of all assay related issues.
- Interface with other departments (e.g., QC, Manufacturing, Engineering, QA and Regulatory) to ensure achievement of ImmunityBio’s goals.
- Performs ad-hoc and cross-functional duties and/or projects as 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
Entry Level
