Process Development Specialist
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.
The Process Development Specialist will interface with members of the R&D team to develop processes for producing iPSCs and differentiating iPSCs into cell therapies including T-cells, B cells and other immune cells. This position requires experience in developing processes for production of cell therapies in bioreactors, cell harvest and cryopreservation, and implementation of those processes in a cGMP environment. The Process Development Specialist will establish scale-down bioreactor models and analytics to support high-throughput media and bioreactor optimization studies. The Process Development Specialist will also interface with internal and external GMP manufacturing teams to support tech transfer and provide technical support for process changes and investigations.
- Interface with the R&D teams to provide input on selection of media, reagents and culture methods for early-stage evaluation of differentiation methods and cell line candidates.
- Create process development plan to support manufacturing 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 PSC production, differentiation, harvest and cryopreservation.
- Establish scale-down bioreactor models and analytics to support media optimization and bioreactor optimization studies. Utilize DOE and other statistical methods to evaluate design space of manufacturing operations, identify Key Process Parameters, and optimize manufacturing processes.
- Interface with Analytical Development to identify key assays required to support early-stage PD activities. Provide material to AD and Quality Control to support assay development and qualification activities.
- 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.
- Interface with the Nonclinical Studies team to provide materials for in vivo studies to demonstrate POC and evaluate key process decisions, selection of Drug Product formulation, and evaluation of cell therapy delivery methods.
- BS in engineering, biological sciences or other relevant discipline with 5+ years of relevant industry experience required or MS/PhD with equivalent experience
- Experience in upstream process development and GMP manufacturing of biologics is required, experience in cell therapy manufacturing is a plus
- Experience in optimization of bioreactors and cell culture media with experience in Design of Experiment (DoE) is highly desirable
- Experience in analysis of cells/media including cell counting, media analysis and flow cytometry is also desirable
- Knowledge of Current Good Manufacturing Practices (cGMP) and the impact of process design and raw material selection on GMP compliance and regulatory risks
- 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.