Senior Manager, Cell Therapy Process Development & MSAT

Clinical Dynamix, Inc.; Germantown (MD); Presencial; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Equity participation

Comprehensive benefits

Descripción de la vacante

Clinical Dynamix, Inc. is seeking an experienced Senior Scientist/Manager to lead Process Development and MSAT for our cell therapy pipeline. You will design, optimize, and scale manufacturing processes and drive tech transfer to both internal GMP manufacturing and external CDMOs.

You will mentor staff and ensure GMP-compliant workflows across R&D, Manufacturing, Quality, Regulatory, and Clinical teams. The role requires strong leadership, hands-on cGMP experience, and a track record of

Formación

• MS/PhD required in a life sciences field.
• Industry experience in biotech, cell therapy, or immunotherapy.
• Hands-on cGMP process development/manufacturing experience.
• Knowledge of GLP/GMP environments and documentation practices.
• Experience leading technology transfer to CDMOs and scale-up.
• Strong ability to analyze data and formulate conclusions.
• Proven cross-functional collaboration and project management skills.

Responsabilidades

• Lead design, optimization, and scale-up of manufacturing processes for cell therapy products.
• Oversee technology transfer to internal GMP and external CDMOs.
• Direct feasibility studies and process evaluations for efficient production.
• Collaborate with Analytical Development to set in-process controls and release criteria.
• Develop and maintain SOPs, batch records, and process control plans.
• Drive continuous process improvements for quality, yield, and throughput.
• Ensure all activities comply with cGMP and regulatory standards.

Conocimientos

Immunology

cGMP experience

Technology transfer

Process development

Cross-functional leadership

Educación

MS/PhD in Immunology, Bioengineering, Cell Biology, Cancer Biology, Biomedical Sciences

Descripción del empleo

Clinical Dynamix, Inc. is seeking an experienced Senior Scientist/Manager to lead Process Development and MSAT for our cell therapy pipeline. You will design, optimize, and scale manufacturing processes and drive tech transfer to both internal GMP manufacturing and external CDMOs.

You will mentor staff and ensure GMP-compliant workflows across R&D, Manufacturing, Quality, Regulatory, and Clinical teams. The role requires strong leadership, hands-on cGMP experience, and a track record of