mRNA Process Development Senior Scientist

About the role

We are seeking a Process Development Scientist to join the messenger-RNA (mRNA) process development team. The successful candidate will contribute to process characterization and tech transfer of programs in clinical development, with knowledge of GMP regulatory expectations for biologic gene-edited material. Direct experience developing, characterizing, scaling, or supporting GMP processes for mRNA is strongly preferred.

Responsibilities

• Design, execute, and analyze experiments to develop and optimize mRNA process characterization techniques.
• Evaluate process performance and identify opportunities for productivity improvements.
• Support the transition of development-stage processes toward GMP-compliant manufacturing by establishing scalable, robust, and well-characterized process parameters.
• Develop scalable processes for plasmid DNA production using fermentation systems.
• Operate and troubleshoot bioreactors/fermenters.
• Develop, execute, optimize, and troubleshoot in vitro transcription (IVT) process development activities.
• Develop, execute, optimize, and troubleshoot chromatography systems including Cytiva AKTA Avant for purification process development and scale-up studies.
• Develop, execute, optimize, and troubleshoot chromatography systems including Agilent 1260 HPLC/UHPLC systems for nucleic acid analysis, impurity profiling, quantitation, and process characterization.
• Analyze and interpret data to support process optimization, troubleshooting, and technology transfer activities.
• Author and review GMP-relevant technical reports, protocols, batch records, and development summaries.
• Present findings to management and project teams.
• Uphold lab safety to the highest level of standards.

Qualifications

• B.S. degree in chemistry, chemical engineering, or biochemistry (or related field) with 4+ years of relevant laboratory experience.
• M.S. degree in chemistry, chemical engineering, or biochemistry (or related field) with 2+ years of relevant laboratory experience.
• Ph.D. in chemistry, chemical engineering, or biochemistry (or related field) with at least 6 months of relevant laboratory experience.
• Experience supporting the process development and manufacturing of protein, AAV, or mRNA therapeutics (experience with mRNA process development is preferred).
• Experience with process characterization and validation studies.
• Working knowledge of cGMP regulations and technology transfer activities.
• Experience with IVT processes and operating bioreactors/fermenters.
• Experience with downstream purification and analytical processes: TFF and chromatography including Akta Avant and Agilent 1260 systems (experience with ELISA is a plus).
• Excellent communication, technical writing, and presentation skills.
• Strong attention to detail, organizational, work planning, problem solving, and critical thinking skills.
• Ability to work independently and autonomously with little supervision.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Benefits

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.
• Eligibility for yearly goal-based bonus & merit-based increases.

Pay

$40.00-$46.00 per hour based on education and related experience.

Schedule

Full Time, Monday-Friday, 8am-5pm.

Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.