Senior MSAT Process Engineer, Cell Therapy & Tech Transfer

SwiftCruit; Gaithersburg (MD); On-site; USD 96,196 - 144,295; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision coverage

Job summary

SwiftCruit is looking for a professional to lead technical oversight in cell therapy manufacturing. The role involves ensuring compliance, developing frameworks for process validation, and maintaining high-quality standards.

Candidates must have a Ph.D. with 1+ years or an M.S. with 5+ years of experience in the biologics industry. The position provides a competitive salary and a comprehensive benefits package including health coverage and retirement plans.

Qualifications

• Technical expertise in cell therapy manufacturing processes and technologies.
• Experience in process validation and CPV.
• Background in GMP manufacturing operations.

Responsibilities

• Represent Global MSAT in technology transfer teams.
• Communicate manufacturing operations needs to CMC team.
• Develop PPQ readiness framework for manufacturing sites.
• Provide technical oversight across cell therapy lifecycle.

Skills

Cell therapy manufacturing processes

Process validation

Technical development

Regulatory compliance

Education

Ph.D. in Chemical/Biochemical/Biomedical Engineering

M.S. in a related discipline

B.S. in a related discipline

Tools

GMP manufacturing operations

Regulatory submissions authoring

Job description

SwiftCruit is looking for a professional to lead technical oversight in cell therapy manufacturing. The role involves ensuring compliance, developing frameworks for process validation, and maintaining high-quality standards.

Candidates must have a Ph.D. with 1+ years or an M.S. with 5+ years of experience in the biologics industry. The position provides a competitive salary and a comprehensive benefits package including health coverage and retirement plans.