Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

The Scientist provides analytical leadership for all aspects of advanced analytical chemistry technologies and methods within the Quality Control characterization area. The role will be responsible for the provision of analytical chemistry methods, data and information using analytical techniques.  The assets involved in cell therapy, therapeutic proteins, and gene therapies within the clinical or commercial environment.  Active participation in cross functional teams within the internal/external sites will be required while providing the analytical technical leadership and perspective to meet the quality system.

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 teams to improve the state of validation and drive analytical variability reduction.
• Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance.
• 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.
• Ensure the appropriate training and execution of all test methods from quality control staff.
• 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 other special projects and duties as requested.

Education & Experience

• Master’s degree in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 7 years of pharmaceutical analytical chemistry experience or Ph.D. in Analytical Science (chemistry, biochemistry, or other scientific related field) at least 3 years of pharmaceutical analytical chemistry experience required.
• Extensive experience with assay development, qualification, validation, and transfer activities.
• Experience with a fast-paced Biotech start-up/ pharmaceutical company preferred.

Knowledge, Skills, & Abilities

• Deep technical expertise in analytical chemistry techniques, in separation sciences, biophysical and mass spectrometry techniques.
• 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.
• In-depth knowledge of GMPs, SOPs and pharmaceutical regulations.
• Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
• Understanding of GMPs 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.
• Ability to multi-task and prioritize with excellent project management skills.

Working Environment / Physical Environment

• This role will work on site in Culver City, CA.
• Flexibility in working schedule, i.e., off-hours, second shift and weekends as needed.
• Performs work in the lab as needed to supervisor staff and oversee quality control programs.
• Performs work in the lab to execute experiments.
• Must possess mobility to work in an office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.
• This role may need to travel up to 15% of the time

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.

$117,000 (entry-level qualifications) to $148,000 (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.