The posting
We are seeking a highly motivated and rigorous Scientist to join the Analytical Development team to support the development, optimization and validation of molecular analytical methods for Kenai Therapeutic’s programs from early development through to commercial launch. The Scientist will work closely within the CMC team to consistently deliver quality data by maintaining continuous operations of extraction, manipulation and analysis of genetic material using various molecular biology techniques. The candidate will have expertise in molecular biology based analytical assay design and development, data analysis and presentation, robust experience with molecular biology related instrumentation operation and maintenance, and good documentation practices for project execution in a fast-paced biotech environment. This role is on-site in San Diego, CA and reports to the Director of Analytical Development.
Responsibilities
- Lead assay design, development and qualification/validation of molecular biology assays such as ddPCR, qPCR, etc.
- Independently design, plan, troubleshoot and execute all aspects of laboratory daily activities, including instrument setup, sample preparation, assay execution and data analysis using industry standard software packages.
- Maintain and manage cell lines/banks used in analytical assay development work.
- Implement scientifically sound design strategies and establish standardized work templates.
- Design and perform phase appropriate assay robustness studies following regulatory guidelines.
- Generate, analyze, interpret and present scientific data in cross-functional meetings.
- Maintain detailed records of executed lab work and reported results and data interpretation using electronic lab notebooks.
- Apply statistical data analysis techniques using JMP, GraphPad Prism etc., to support experimental design and data interpretation.
- Prepare assay development/technical reports, protocols, standard operating procedures and other relevant documents following industry standard documentation practices.
- Conduct risk/gap assessments for method development and optimization at various phases of program lifecycle.
- Ensure assays are fit-for-purpose and aligned with phase-appropriate regulatory expectations by exhibiting a strong understanding of regulatory principles for cell therapy industry as applicable to analytical development and validation activities.
- Keep current on relevant scientific literature, new technologies/capabilities and support their implementation, as appropriate.
- Partner with Process Development, Quality, Research teams and external CRO’s and vendors to ensure analytical readiness for clinical milestones.
- Support method transfers, qualification and validation of assays in GMP environments to support drug product release and lifecycle management.
- Demonstrate excellent written, verbal and interpersonal communication skills.
Requirements
Required Qualifications
- Ph.D. in Immunology, Cell Biology, Neuroscience or related field with 2-3 years or M.S. with 6+ years of analytical development relevant industry experience.
- Strong analytical skillset with deep expertise in various molecular biology assay development techniques, analysis, and data interpretation.
- Hands-on experience with cell handling of suspension/adherent cultures of mammalian cells in BSC operations.
- Strong understanding of ICH guidelines for analytical method development and validation and phase appropriate method lifecycle management.
- Extensive experience in operating and maintaining advanced PCR, spectroscopic and molecular instruments including Qiagen, ThermoFisher, Biorad platforms etc. and their associated softwares such as QuantStudio, QX Manager, Quantasoft for operations and data analysis.
- Familiarity with advanced statistical approaches for assay development and validation using JMP, Prism or equivalent tools.
- Scientifically strong technical writing skills.
- Good understanding of cell therapy product development and characterization.
- Excellent organization and time management skills to work independently and balance multiple tasks and projects.
- Ability to clearly analyze and communicate scientific findings and development rationale.
- Ability to work in a small, fast-paced cross collaborative environment with strong listening, communication and collaboration skills.
Preferred Qualifications
- Experience supporting clinical programs from early phase to commercialization.
- Working experience with mammalian cell culture, flow cytometry assays and cell-based assays.
- Experience in assay transfers between CDMO’s and CRO’s and internal teams.
- Prior experience in a startup or early-phase biotech environment.
Benefits
Additional Detail:
The salary range for this position is $110,000 USD to $135,000 USD annually. This salary range is an estimate, and the actual salary may vary based on experience and/or the Company’s compensation practices.
Kenai Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
