Senior Scientist, Cell Therapy Process Development & MSAT

Planet Pharma; Germantown (MD); On-site; USD 110,000 - 180,000; Full time

Job summary

Planet Pharma in Germantown, MD seeks a Senior Scientist or Manager to lead Process Development and MSAT for our cell therapy pipeline.

You will own design, optimization, and scale-up of GMP manufacturing processes, and drive technology transfer to internal GMP manufacturing and external CDMOs, partnering with R&D, Manufacturing, QA, Regulatory, and Clinical teams to advance immunotherapy products toward the clinic.

Qualifications

• Hands-on cGMP PD/manufacturing experience.
• Experience leading technology transfer to CDMOs.
• Background in immunotherapy or cell therapy.
• Strong documentation and regulatory support skills.

Responsibilities

• Lead design, optimization, and scale-up of manufacturing processes for cell therapy products.
• Oversee technology transfer to internal GMP manufacturing and CDMOs.
• Conduct feasibility studies and process evaluations for cost efficiency.
• Collaborate with Analytical Development for in-process controls and release criteria.
• Develop and maintain SOPs, batch records, and control plans.
• Drive continuous process improvement to enhance quality and throughput.
• Ensure all activities comply with cGMP and regulatory standards.
• Mentor scientists and engineers; cross-functional representation in meetings.
• Coordinate with Quality, Regulatory, and external partners for compliance.

Skills

cGMP PD

Team leadership

Regulatory docs

Data analysis

Mentoring

Cross-functional

Project management

SOPs writing

Education

MS/PhD in Immunology or related

Tools

Flow cytometry

Job description

Planet Pharma in Germantown, MD seeks a Senior Scientist or Manager to lead Process Development and MSAT for our cell therapy pipeline.

You will own design, optimization, and scale-up of GMP manufacturing processes, and drive technology transfer to internal GMP manufacturing and external CDMOs, partnering with R&D, Manufacturing, QA, Regulatory, and Clinical teams to advance immunotherapy products toward the clinic.