Experienced Scientist, Biotherapeutics RD

Scorpion Therapeutics; Spring House (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking an Experienced Scientist in Biotherapeutics R&D for autologous CAR-T manufacturing, leading the on-the-floor operations in a Phase 1/2a program.

The role focuses on cGMP cell therapy production, troubleshooting, technical documentation, audits, and regulatory interactions. On-site in Spring House, PA, with opportunities to advance process improvements and mentor staff.

Qualifications

• Bachelor’s degree with 5+ years of GMP CAR-T or cell/gene therapy manufacturing experience.
• Leadership in GMP environments demonstrated in past roles.
• Knowledge of FDA and international regulations for cell-based products.

Responsibilities

• Overseeing on-the-floor cGMP cell therapy manufacturing.
• Troubleshooting process/equipment issues.
• Authoring technical documents and supporting audits.
• Ensuring safety, quality, and regulatory compliance.
• Training staff and driving process improvements.
• Serving as SME during regulatory inspections.

Skills

Leadership in GMP environments

Regulatory knowledge (FDA/intl)

Project management

Education

Bachelor’s degree in a related field

Tools

SAP

MES

LIMS

Change control

Job description

Role

Experienced Scientist, Biotherapeutics R&D at Johnson & Johnson, leading the manufacturing team for autologous CAR-T products in Phase 1/2a clinical trials.

Responsibilities

• overseeing on-the-floor cGMP cell therapy manufacturing
• troubleshooting process/equipment issues
• authoring technical documents
• ensuring compliance with safety, quality, and regulatory standards
• supporting audits
• training staff
• driving process improvements
• serving as SME during regulatory inspections

Qualifications

• Bachelor’s degree with at least 5 years of GMP experience in CAR-T or cell/gene therapy manufacturing
• leadership in GMP environments
• knowledge of FDA and international regulations for cell-based products

Preferred Skills

• project management
• experience with SAP, MES, LIMS, and change control systems

High-Value Specifics

• focus on autologous CAR-T production
• Phase 1/2a clinical trials
• sterile/aseptic processing
• regulatory audit support

Location

Spring House, PA, with a requirement for on-site work.