mRNA Process Development Senior Scientist

Eurofins PSS Insourcing Solutions; Boston (MA); On-site; USD 55,000 - 63,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a Process Development Scientist to join the messenger-RNA (mRNA) process development team in Boston. The successful candidate will contribute to process characterization and tech transfer of programs in clinical development, with knowledge of GMP expectations for biologic gene edited material.

Responsibilities include designing, executing, and optimizing mRNA process characterization experiments; developing scalable plasmid DNA production

Qualifications

• Bachelor's or higher in chemistry, chemical engineering, or biochemistry with relevant lab experience.
• Experience with protein, AAV, or mRNA therapeutics process development.
• Knowledge of cGMP regulations and technology transfer activities.
• Experience with IVT processes and operating bioreactors/fermenters.

Responsibilities

• Design, execute, and analyze experiments to develop and optimize mRNA process characterization techniques.
• Evaluate process performance and identify opportunities for productivity improvements.
• Support GMP transfer by establishing scalable, robust process parameters.
• Develop scalable plasmid DNA production processes using fermentation systems.
• Operate and troubleshoot bioreactors/fermenters.
• Develop, execute, optimize IVT process development activities.
• Develop chromatography systems for purification process development and scale-up.
• Analyze and interpret data to support process optimization and technology transfer.
• Prepare GMP-relevant reports, protocols, batch records, and development summaries.
• Present findings to management and project teams.

Skills

Communication skills

Technical writing

Presentation skills

Independent worker

Education

Bachelor's/PhD in chemistry, chemical engineering, or biochemistry

MS in related field

PhD in related field

Tools

AKTA Avant

Agilent 1260 UHPLC

Bioreactors/fermenters

TFF/filtration

Job description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

Job Description

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.