mRNA Process Development Senior Scientist

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.

Qualifications :

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 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.

Additional Information :

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 options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases
• Compensation: $40.00-$46.00 per hour based on education and related experience

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time