Senior Engineer II, mRNA Process Development
CRISPR Therapeutics
4 days ago
On-site
Boston, MA
Operations
Position Summary
Senior Engineer II (Non-viral delivery technical development) leading design, optimization, and scale-up of robust manufacturing processes for gene editing mRNA therapeutics; bridging research and clinical development; driving technical strategy and mentoring.
Responsibilities
- Lead development, optimization, and scale-up of upstream and downstream unit operations for mRNA drug substance.
- Apply Design of Experiments (DoE) and statistical analysis to evaluate 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.
- Represent technical development in cross-functional teams and present data to senior leadership.
Minimum Qualifications
- Ph.D. in Chemical Engineering/Bioengineering/Biochemistry (2–4.5+ years industry) OR non-PhD (10–12 years relevant experience).
- Hands-on mRNA expertise: IVT kinetics; plasmid DNA linearization.
- Downstream purification: Tangential Flow Filtration; chromatography (Affinity, IEX, RP-HPLC).
- Equipment: automated chromatography systems (e.g., ÄKTA Avant/Pure) and filtration skids.
- Data analysis: JMP or 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/Location
On-site manufacturing/lab roles.
Base pay range: $140,000–$150,000+ bonus, equity, and benefits.
Application instructions
Not specified.
Senior Engineer II (Non-viral delivery technical development) leading design, optimization, and scale-up of robust manufacturing processes for gene editing mRNA therapeutics; bridging research and clinical development; driving technical strategy and mentoring.
Responsibilities
- Lead development, optimization, and scale-up of upstream and downstream unit operations for mRNA drug substance.
- Apply Design of Experiments (DoE) and statistical analysis to evaluate 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.
- Represent technical development in cross-functional teams and present data to senior leadership.
Minimum Qualifications
- Ph.D. in Chemical Engineering/Bioengineering/Biochemistry (2–4.5+ years industry) OR non-PhD (10–12 years relevant experience).
- Hands-on mRNA expertise: IVT kinetics; plasmid DNA linearization.
- Downstream purification: Tangential Flow Filtration; chromatography (Affinity, IEX, RP-HPLC).
- Equipment: automated chromatography systems (e.g., ÄKTA Avant/Pure) and filtration skids.
- Data analysis: JMP or 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/Location
On-site manufacturing/lab roles.
Base pay range: $140,000–$150,000+ bonus, equity, and benefits.
Application instructions
Not specified.