Senior Engineer II, mRNA Process Development
CRISPR Therapeutics
August 07, 2026
On-site
Boston, MA
Operations
Responsibilities:
- Lead the 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 process parameters, improve yields, and ensure consistent product quality attributes.
- Drive tech transfer of developed processes to internal clinical manufacturing teams or external CDMOs.
- Author technical reports, Standard Operating Procedures, batch records, and tech transfer documentation.
- Provide on-the-floor technical support and troubleshooting during scale-up and GMP manufacturing runs.
- Partner with analytical development to correlate process changes with mRNA quality attributes.
- Mentor, coach, and guide 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, 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 and plasmid DNA linearization.
- Downstream purification: Tangential Flow Filtration and chromatography (Affinity, IEX, RP-HPLC).
- Equipment: experience operating automated chromatography systems (e.g., ÄKTA Avant/Pure) and filtration skids.
- Data analysis: JMP or Minitab for DoE and data analysis.
Preferred Qualifications:
- Experience with mRNA-LNP formulation.
- Familiarity with GMP, Quality by Design, and regulatory filing documentation.
- Prior experience mentoring junior researchers.
Benefits/Compensation:
- Senior Engineer II: Base pay range of $140,000 to $150,000+ bonus, equity and benefits.
Application Instructions:
- Not provided.
- Lead the 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 process parameters, improve yields, and ensure consistent product quality attributes.
- Drive tech transfer of developed processes to internal clinical manufacturing teams or external CDMOs.
- Author technical reports, Standard Operating Procedures, batch records, and tech transfer documentation.
- Provide on-the-floor technical support and troubleshooting during scale-up and GMP manufacturing runs.
- Partner with analytical development to correlate process changes with mRNA quality attributes.
- Mentor, coach, and guide 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, 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 and plasmid DNA linearization.
- Downstream purification: Tangential Flow Filtration and chromatography (Affinity, IEX, RP-HPLC).
- Equipment: experience operating automated chromatography systems (e.g., ÄKTA Avant/Pure) and filtration skids.
- Data analysis: JMP or Minitab for DoE and data analysis.
Preferred Qualifications:
- Experience with mRNA-LNP formulation.
- Familiarity with GMP, Quality by Design, and regulatory filing documentation.
- Prior experience mentoring junior researchers.
Benefits/Compensation:
- Senior Engineer II: Base pay range of $140,000 to $150,000+ bonus, equity and benefits.
Application Instructions:
- Not provided.