About this role
We are seeking a process development scientist to join the messenger-RNA (mRNA) process development team. The successful candidate will be contributing to process characterization and tech transfer of programs in clinical development. In this role, the successful candidate will have knowledge of GMP regulatory expectations for biologic gene edited material. Direct experience developing, characterizing, scaling, or supporting GMP processes for mRNA is strongly preferred.
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. Basic Minimum 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 skillsStrong 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.
Position is Full Time, Monday-Friday, 8am-5pm. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEligibility for yearly goal-based bonus & merit-based increasesCompensation: $40.00-$46.00 per hour based on education and related experienceEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.