Position Summary
The Senior Scientist, Quality Control Analytical provides analytical testing leadership for various programs such as fusion proteins, cell therapies and cancer vaccines. The analytical testing will include but is not limited to the wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will also take on a lead role for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, transfer, qualification work and investigational studies. The Senior Scientist will undertake complex troubleshooting and investigations.
Essential Functions
- Develop strategies, and support the introduction, validation and on-going technical agenda for pipeline and commercial analytical chemistry methods and technology. Including:
- The polishing of analytical methods to implement GMP-friendly structure into the method.
- Drafting and reviewing of protocols, reports, and methods to support the method validation lifecycle.
- Complex troubleshooting of methods
- Development of new assays to support raw material, in process, drug substance, or drug product release and stability testing.
- As required, provide training or mentorship to other QC or cross functional team members.
- Act as Subject Matter Expert (SME) for analytical chemistry within QC. This may include the identification, purification and separation of the components in an unknown mixture.
- Complete structural analytical characterization (via experimental analysis or review of outsource reports) on various drug products, including product related impurities.
- In the event of non-conformance to acceptable quality and/or safety standards (including invalid assays), lead analytical investigations, using Root Cause Analysis techniques where appropriate. Work with the QC team to improve the state of validation and drive analytical variability reduction.
- Draft and edit documents, Standard Operating Procedures (SOPs) and test plans as needed.
- Lead continuous improvement activities to help improve the overall operations of the testing labs.
- Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
- Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
- Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
Education & Experience
- Master’s degree in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 7 years of experience in the biotechnology industry required; or
- Ph.D. in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 3 years of experience in the biotechnology industry required.
- Extensive experience with assay development, qualification, validation, and transfer activities.
- Experience working in cGMP laboratory required
- Hands-on experience with HPLC and ELISA required
- Hands-on experience with biological assays (e.g. cell cultures) preferred
Knowledge, Skills, & Abilities
- Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance
- Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
- With safety as the priority excellent laboratory techniques
- Proficiency in the use of multiple HPLC instrument platforms (e.g. Thermo, Agilent, etc.)
- Strong technical problem-solving ability both independently and as part of a team.
- Motivated to work independently to produce high quality work in an efficient manner.
- Strong computer skills, including Microsoft Office
- High attention to detail in all aspects of the work
- Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously.
- Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities.
- In-depth knowledge in analytical method development and validation, and statistical quality control.
- Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
- Deep understanding of GMPs, SOPs, and pharmaceutical regulations, and an ability to interpret and enforce regulatory requirements.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to analyze and interpret complex, scientific documents, including problem solving.
Working Environment / Physical Environment
- This position works on site in Dunkirk, NY
- Flexibility in working schedule, i.e., off-hours
- Performs work in the lab as needed to supervisor staff and oversee quality control programs.
- Performs work in the lab to execute experiments.
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.
$125,000 (entry-level qualifications) to $137,500 (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 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.
