Director, Cell Therapy Process Development & Transfer

Actalent; Frederick (MD); On-site; USD 215,000 - 275,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life and AD&D coverage

401(k) retirement plan

Employee stock purchase plan

Job summary

Actalent in Frederick, MD seeks a Director of Process Development Scientist to lead development, characterization, technology transfer, and commercialization of autologous cell therapy processes. You will ensure robust, scalable processes for regulatory submissions, validation, and manufacturing.

The role provides technical leadership across process development, validation planning, comparability assessments, and regulatory support, partnering with Manufacturing, Quality, Regulatory Affairs,

Qualifications

• PhD or equivalent advanced degree in Chemical Engineering, Biomedical Engineering, Biological Sciences, Pharmaceutical Sciences, or related field.
• 10+ years of biopharmaceutical or cell therapy experience with leadership responsibilities.
• Experience in GMP-regulated process development and technology transfer.

Responsibilities

• Lead process development activities supporting clinical and commercial programs.
• Develop strategies to improve process robustness, consistency, scalability and manufacturability.
• Generate process understanding through characterization studies and data analysis.
• Establish process design space, operating ranges and performance requirements.
• Lead transfer of processes to manufacturing and support PPQ activities.
• Collaborate with QA, Regulatory, Analytical Development to ensure compliance.

Skills

Process development

Technology transfer

DOE

Statistical design

GMP

Validation principles

Leadership

Biopharma/cell therapy

Education

PhD or equivalent in Chemical Engineering / Biomedical Engineering / Biological Sciences / Pharmaceutical Sciences / related field

Job description

Actalent in Frederick, MD seeks a Director of Process Development Scientist to lead development, characterization, technology transfer, and commercialization of autologous cell therapy processes. You will ensure robust, scalable processes for regulatory submissions, validation, and manufacturing.

The role provides technical leadership across process development, validation planning, comparability assessments, and regulatory support, partnering with Manufacturing, Quality, Regulatory Affairs,