Senior Engineer II, mRNA Process Development

CRISPR Therapeutics•Boston, MA

2d•$140,000 - $150,000•Onsite

About The Position

We are seeking a highly motivated and innovative Senior Engineer II to join our Non-viral delivery technical development team. In this role, you will lead the design, optimization, and scale-up of robust manufacturing processes for our gene editing mRNA therapeutics. You will bridge the gap between research innovation and clinical development, utilizing your deep technical expertise in nucleic acid chemistry, enzymatic reactions, and purification methodologies. As a senior member of the team, you will drive technical strategy, mentor junior staff, and collaborate closely with research innovation, analytical development, and manufacturing operations to advance our pipeline.

Requirements

Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or a related discipline with 2-4.5+ years of industry experience; OR Non PhD and 10-12 years of relevant experience
Core mRNA Expertise: Hands-on, deep expertise in in vitro transcription (IVT) kinetics, plasmid DNA linearization.
Downstream Purification: Extensive experience with purification techniques including Tangential Flow Filtration and various chromatography modes (e.g., Affinity, IEX, RP-HPLC).
Equipment Proficiency: Experience operating automated chromatography systems (e.g., ÄKTA Avant/Pure) and filtration skids.
Data Analysis: Proficiency with statistical software (e.g., JMP, Minitab) for DoE design and data analysis.

Nice To Haves

Experience with mRNA-LNP formulation.
Familiarity with GMP regulations, Quality by Design principles, and preparing regulatory filing documentation.
Prior experience managing or directly mentoring junior researchers.

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 systematically evaluate process parameters, improve yields, and ensure consistent product quality attributes.
Drive the tech transfer of developed processes to internal clinical manufacturing teams or external CDMOs.
Author clear, comprehensive 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, fostering a collaborative and high-performing laboratory culture.
Represent the technical development function in cross-functional project teams and present data to senior leadership.