Downstream Process Engineer - mRNA GMP & Tech Transfer

Crispr Therapeutics Inc; Boston (MA); On-site; USD 97,000 - 108,000; Full time

Job summary

CRISPR Therapeutics Inc. is seeking an Engineer III to own downstream process development for mRNA drug substance and to transfer processes into GMP production at external CDMOs. You will design, develop, and scale the purification process from bench to pilot scale, then facilitate technical transfer and GMP campaigns at partner sites.

This engineering-forward role is externally facing. The position requires BS in Chemical/Bioengineering with 4–6+ years in downstream processing, chromatography,

Qualifications

• BS in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with 4-6+ years of relevant industry experience; MS with 2-5+ years
• Hands-on downstream process development experience with biologics or nucleic acids, including chromatography and TFF at bench and pilot scale
• Demonstrated scale-up experience and a working command of mass balance, sizing, and engineering fundamentals
• Direct experience transferring a process to an external manufacturing partner, including transfer documentation
• Experience with DoE and statistical analysis (JMP, Design-Expert, or equivalent)

Responsibilities

• Own downstream technology transfer to CDMOs end to end: transfer packages, process descriptions, scale parameter tables, risk assessments
• Review and approve partner-generated documents and ensure critical parameters are maintained
• Assist with technical readiness for campaigns; run risk reviews and define escalation paths
• Serve as person-in-plant at partner sites for real-time data review and troubleshooting
• Drive post-campaign data review, yield and impurity reconciliation, and CAPA input

Skills

Downstream process development

Scale-up experience

Mass balance & sizing

DoE & statistical analysis

Communication with partners

Education

BS in Chemical Engineering/Bioengineering

MS optional with 2–5+ years

Tools

JMP

Design-Expert

Job description

CRISPR Therapeutics Inc. is seeking an Engineer III to own downstream process development for mRNA drug substance and to transfer processes into GMP production at external CDMOs. You will design, develop, and scale the purification process from bench to pilot scale, then facilitate technical transfer and GMP campaigns at partner sites.

This engineering-forward role is externally facing. The position requires BS in Chemical/Bioengineering with 4–6+ years in downstream processing, chromatography,