Senior Engineer II, mRNA Process Development
CRISPR Therapeutics
June 25, 2026
On-site
Boston, MA
Operations
Position Summary
Senior Engineer II (Non-viral delivery technical development). Lead design, optimization, and scale-up of manufacturing processes for gene editing mRNA therapeutics; bridge research and clinical development; drive technical strategy, mentor team members, and collaborate across R&D, analytical development, and manufacturing.
Responsibilities
- Lead upstream and downstream unit operations development, optimization, and scale-up for mRNA drug substance.
- Use DoE and statistical analysis to evaluate process parameters, improve yields, and ensure consistent quality attributes.
- Drive tech transfer to internal clinical manufacturing teams or external CDMOs.
- Author technical reports, SOPs, batch records, and tech transfer documentation.
- Provide on-the-floor technical support and troubleshooting during scale-up and GMP runs.
- Partner with analytical development to correlate process changes with mRNA quality attributes.
- Mentor/coach research associates and engineers; foster a collaborative lab culture.
- Represent technical development in cross-functional teams and present data to senior leadership.
Minimum Qualifications
- Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or related field with 2–4.5+ years industry experience; or Non-PhD with 10–12 years relevant experience.
- Core mRNA expertise: hands-on in vitro transcription (IVT) kinetics; plasmid DNA linearization.
- Downstream purification: TFF and chromatography (Affinity, IEX, RP-HPLC).
- Equipment: automated chromatography (e.g., ÄKTA Avant/Pure) and filtration skids.
- Data analysis: JMP/Minitab for DoE and analysis.
Preferred Qualifications
- mRNA-LNP formulation experience.
- GMP regulations, Quality by Design, and regulatory filing documentation.
- Experience mentoring junior researchers.
Compensation/Benefits (if applicable)
- Base pay range: $140,000–$150,000+ plus bonus, equity and benefits.
Application Instructions
- Not specified.
Senior Engineer II (Non-viral delivery technical development). Lead design, optimization, and scale-up of manufacturing processes for gene editing mRNA therapeutics; bridge research and clinical development; drive technical strategy, mentor team members, and collaborate across R&D, analytical development, and manufacturing.
Responsibilities
- Lead upstream and downstream unit operations development, optimization, and scale-up for mRNA drug substance.
- Use DoE and statistical analysis to evaluate process parameters, improve yields, and ensure consistent quality attributes.
- Drive tech transfer to internal clinical manufacturing teams or external CDMOs.
- Author technical reports, SOPs, batch records, and tech transfer documentation.
- Provide on-the-floor technical support and troubleshooting during scale-up and GMP runs.
- Partner with analytical development to correlate process changes with mRNA quality attributes.
- Mentor/coach research associates and engineers; foster a collaborative lab culture.
- Represent technical development in cross-functional teams and present data to senior leadership.
Minimum Qualifications
- Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or related field with 2–4.5+ years industry experience; or Non-PhD with 10–12 years relevant experience.
- Core mRNA expertise: hands-on in vitro transcription (IVT) kinetics; plasmid DNA linearization.
- Downstream purification: TFF and chromatography (Affinity, IEX, RP-HPLC).
- Equipment: automated chromatography (e.g., ÄKTA Avant/Pure) and filtration skids.
- Data analysis: JMP/Minitab for DoE and analysis.
Preferred Qualifications
- mRNA-LNP formulation experience.
- GMP regulations, Quality by Design, and regulatory filing documentation.
- Experience mentoring junior researchers.
Compensation/Benefits (if applicable)
- Base pay range: $140,000–$150,000+ plus bonus, equity and benefits.
Application Instructions
- Not specified.