Analytical Method Development Associate
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, located in Kendall Square, 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.
The Analytical Method Development Specialist will interface with members of the R&D team to develop methods for analyzing iPSCs and iPSC-derived cell therapies including T-cells, B cells, NK cells and other immune cells. This position requires experience in developing analytical methods for cell therapies including flow cytometry, single cell RNAseq and PCR-based methods for both in-process testing and release testing of cell therapies. The Analytical Development Specialist will establish high-throughput analytical methods to support media and bioreactor optimization studies performed by the Process Development group. The Analytical Method Development Specialist will also interface with internal Quality Control and external CROs /CDMOs to support analytical method tech transfer, qualification/validation and OOS and assay related investigations.
- Design and develop analytical methods so support early-stage activities including cell line evaluation and process development. Collaborate with R&D to identify potential new analytical methods and targets for further development.
- Create analytical method development plans 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 PSCs and iPSC-derived cell therapies.
- Support process development efforts by establishing analytics to inform media optimization and bioreactor optimization studies. Utilize flow cytometry, ddPCR and scRNAseq to characterize process intermediates and cell therapy products for gene editing processes (e.g., off-target analysis) and 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. 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.
- BS in biological sciences, engineering sciences or other relevant discipline with 5+ years of relevant industry experience required or MS/PhD with equivalent experience
- Experience in flow cytometry and/or ddPCR analysis of cell therapies is required, experience in analysis of iPSC or CAR-T Drug Products is a plus
- Experience in optimization of analytical methods and statistical analysis of data including the use of Design of Experiment (DoE) is highly desirable
- 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
- 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.