Senior Engineer II, mRNA Process Development

## Senior Engineer II, mRNA Process Development Apply remote type:
Site Based locations:
South Boston, MAtime type:
Full time posted on:
Posted 6 Days Agojob requisition :
R-100084
*
* Job Description:

**** Company Overview
** Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.

CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTaseTM editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals.

CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
** Position Summary
** 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.
** 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.
** Minimum Qualifications**
* ** 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.
** Preferred Qualifications
*** Experience with mRNA-LNP formulation.
* Familiarity with GMP regulations, Quality by Design principles, and preparing regulatory filing documentation.
* Prior experience managing…