mRNA Process Development Senior Scientist
Eurofins Professional Scientific Services (PSS) offers a rewarding career in the biopharmaceutical industry, focusing on professional growth and work-life balance. As part of Eurofins Scientific, a global leader in analytical testing services, we ensure the safety and authenticity of products across food, environmental, pharmaceutical, and cosmetics industries. Our teams support genomics, discovery pharmacology, forensics, and clinical studies.
About the role
We are seeking a Process Development Scientist to join our 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 with mRNA process development, including scaling and GMP processes, 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 standards.
Requirements
- 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 (mRNA process development experience 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 (ELISA experience 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.
Schedule
Full Time, Monday-Friday, 8:00 AM–5:00 PM. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.
Pay
$40.00–$46.00 per hour based on education and related experience.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
- Eligibility for yearly goal-based bonus and merit-based increases.