Scientist I / II, Analytical Development
About Clade Therapeutics
Clade Therapeutics is a well-funded, early-stage cell therapy company developing novel cell-based medicines for the treatment of cancer and other devastating diseases. The company was recently founded by an exceptional group of academic leaders and successful bioentrepreneurs. The Company works at the convergence of stem cell biology, immunology, regenerative medicine, and gene editing to create the next-generation of stem cell-derived medicines.
We are passionate about delivering on the promise of cellular therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients.
Position Summary
Responsibilities
- Design and develop molecular analytical methods to support iPSC line engineering and banking activities. Collaborate with Cell Line Engineering and Computational Biology to develop methods for screening iPSC clones to verify gene edits, identify off-target editing events, and assess the genomic stability of iPSC lines.
- Develop analytical methods to support in-process testing and QC release testing for IND-enabling studies, human clinical trials, and process scale-up for late-stage clinical trials and commercial manufacturing. Identify and evaluate technologies, methodologies, and equipment applicable to testing of iPSCs and iPSC-derived cell therapies.
- Support process development efforts by establishing analytics to inform media optimization and bioreactor optimization studies. Utilize flow cytometry, PCR and scRNAseq to characterize process intermediates for the iPSC differentiation processes including analysis for cell impurities, process-related impurities, and potency testing.
- Work with Quality Control to create Drug Product specifications and develop GMP-compliant analytical methods for Drug Product release testing. Provide technical support for assay qualification and validation activities for both internal QC and external CROs/CDMOs.
- Interface with internal and external GMP manufacturing teams to support tech transfer and cell therapy manufacturing activities including support for process changes, troubleshooting and investigations.
- Provide analytical support for non-clinical studies. Generate key data to inform process decisions, selection of Drug Product formulation, and evaluation of cell therapy delivery methods for in vivo studies.
- Work with R&D and Quality Control to develop and evaluate potency assay methods. Support continued evaluation and development of potency assays in parallel with early-stage clinical development.
Qualifications
- PhD in biological sciences, engineering sciences or other relevant discipline with 2+ years of relevant industry experience required or BS/MS with equivalent experience.
- Experience in ddPCR, NGS and molecular analytic methods for cell therapies is required. Experience in flow cytometry and analysis of iPSC or CAR-T Drug Products is a plus.
- Experience in method optimization, method qualification/validation and statistical analysis of data is required.
- Experience in additional analytical methods including cell counting, ELISA, cell-based killing assays and other methods for analysis of process-related impurities is also desirable.
- Knowledge of Drug Product QC testing under Current Good Manufacturing Practices (cGMP) is highly desirable.
Corporate Values
- Patients First – Proactively and constructively engage to deliver results for those in need. “Begin with patient’s success in mind”
- Communication and Respect – Foster open exchange with colleagues and collaborators. Seek to understand and treat people with courtesy. “Better together”
- Integrity & Excellence – Act honestly and ethically to seek the truth. Courageously doing the right thing – take smart risks and make tough decisions in pursuit of exceptional outcomes. “Get it done right”
Clade Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, gender, age, religion, national origin, disability, veteran status, sexual orientation or any characteristic protected under applicable law.