Scientist / Senior Scientist Analytical Development
Department: Process/Analytical Development
Location: South San Francisco
COMPANY INTRODUCTION:
Nkarta Therapeutics is a private biotech start-up that leverages the power of Natural Killer cells for next generation cellular immunotherapies for cancer. NK cells play a key role in the immune system, able to identify and kill abnormal cells and recruit the adaptive immune system. Nkarta is combining its NK expansion platform technology with proprietary cell engineering technologies to develop allogeneic cell therapies for the treatment of challenging diseases with significant unmet clinical need.
We are seeking a highly motivated Scientist / Senior Scientist to join our analytical and process development team. Reporting to the Senior Director of Analytical Development, the Scientist / Senior Scientist will be responsible for developing cell-based characterization, in-process and release assays to support process development and manufacturing, then transferring selected assays to QC. The ideal candidate will be expected to collaborate closely with Nkarta’s discovery, translational research, process development, quality and clinical development groups.
KEY RESPONSIBILITIES:
- Select, design and implement novel cell-based analytical methods to test process intermediates, ancillary products, drug substances and drug products during process development
- Exercise independent judgment in performing experimental methods, techniques, evaluation criteria for obtaining results, and data analysis
- Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions for clinical phase-appropriate assays
- Evaluate and transfer in appropriate research assays and improve their performance
- Provide technical input to enhance current analytical methods
- Write protocols and development reports, and contribute to relevant regulatory filings
- Tech transfer selected assays to in-house and CMO QC groups
- As needed, support specification setting, qualification and validation of assays
- Present scientific results in team meetings and at conferences
REQUIREMENTS:
- In-depth experience with in vivo biology methodologies, including xenograft tumor model testing, tissue processing and analysis by functional assays including flow cytometry, cytokine production, cytotoxicity assays and RNA analysis
- Experience in executing cellular characterization instrumentation including ELISA, MSD, flow cytometry, lymphocyte activation, and immunohistochemistry
- Ability to work on complex problems where analysis requires an evaluation of multiple factors
- Exercises independent judgment in performing experimental methods, techniques, evaluation criteria for obtaining results, and data analysis
- Strong verbal and writing skills for documentation of data, drafting of technical reports, and communication of progress to supervisor and project teams
- Must be able to communicate and multi-task within a fast-paced team environment with a high degree of self-motivation and organization
PROFESSIONAL EXPERIENCE/QUALIFICATIONS:
- A PhD or equivalent in Immunology, Cell Biology or related field with 5+ years of assay development experience in biotech
- Experience in executing cellular characterization via multicolor flow cytometry, qPCR, and cell functional assays is required; experience with imaging platforms is a plus
- Familiarity with FDA, ICH and GMP guidelines is preferred
- Highly organized, detail oriented individual with strong analytical and problem-solving skills
- Excellent written, verbal and interpersonal skills
- Ability to multi-task within a highly collaborative, fast-paced environmentvvvv
Nkarta offers a creative, team-oriented scientific environment, along with a strong compensation package that includes salary, stock options, and a comprehensive benefits package.