Scientist, Process Development

ElevateBio; Waltham (MA); On-site; USD 105,000 - 145,000; Full time

Job summary

ElevateBio is seeking an experienced mRNA Scientist to join our process development team. You will design, execute, and optimize experiments for mRNA production and purification, working with cross-functional teams to support tech transfer of mRNA-based therapeutics.

Responsibilities include developing scale-up processes, characterizing samples with HPLC/UPLC and other analytics, and contributing to SOPs while collaborating with MSAT and external clients.

Qualifications

• BS/MS in Microbiology, Bioengineering, Biochemistry with 8+ years of relevant experience, including 4+ years in mRNA therapeutics
• Hands-on mRNA processing experience including IVT and plasmid DNA linearization
• Experience with downstream mRNA methods (TFF, dT Affinity, IEX, RP-HPLC) and analytics
• Experience operating chromatography systems (ÄKTA Avant/Pure) and filtration skids (Repligen KrosFlow Kr2i)
• Understanding tech transfer activities for mRNA production and scaling from bench to GMP manufacturing
• Familiarity with GMP, Quality by Design, and regulatory filing documentation
• Experience with mRNA-LNP formulation and DoE/data analysis (JMP) is a plus

Responsibilities

• Lead development, optimization, and scale-up of mRNA-based processes for yields and purity
• Characterize RNA samples using electrophoresis, spectrophotometry, and HPLC/UPLC to ensure quality
• Collaborate with MSAT, analytic development, and external clients to support project goals
• Support business development with SOWs and proposals for external mRNA therapeutics partners
• Communicate results and progress to internal and external stakeholders
• Contribute to SOPs and technical documents for processes and transfer

Skills

mRNA processing

In vitro transcription

tech transfer

process scaling

analytical techniques

DoE

GMP

Education

BS/MS in Microbiology, Bioengineering, Biochemistry

Tools

ÄKTA Avant/Pure

Repligen KrosFlow Kr2i

Tangential Flow Filtration (TFF)

dT Affinity

IEX

RP-HPLC

HPLC/UPLC

Automated chromatography systems

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role:

We are seeking a highly skilled mRNA Scientist to join our process development team at ElevateBio. The ideal candidate will have extensive hands-on experience in mRNA synthesis, purification, and characterization. As an mRNA Scientist, you will be responsible for designing, executing, and optimizing experiments related to mRNA production and purification. You will work closely with cross-functional teams to support the tech transfer of mRNA-based therapeutics. Your contributions will be critical in advancing the manufacturing of mRNA-based products here at ElevateBio.

Here’s What You’ll Do:

• Lead the development, optimization, and scale-up experiments for mRNA based processes to achieve desired yields and purity
• Characterize mRNA samples using analytical techniques such as electrophoresis, spectrophotometry, and HPLC/UPLC to ensure product quality and consistency
• Work closely with cross-functional teams, including MSAT, analytical development, and external clients, to support project goals.
• Support the business development team in creating SOWs and proposals for external clients looking to partner for mRNA therapeutics
• Communicate experimental results and progress to internal stakeholders and external clients.
• Contribute to the development of standard operating procedures (SOPs) and technical documents.

Requirements:

Education Requirements

• BS/MS in Microbiology, Bioengineering, Biochemistry, or a related discipline with 8+ years of relevant experience, with a minimum of 4 years in working with mRNA-based therapeutics

Experience Requirements

• Comprehensive mRNA processing experience with hands-on experience in in-vitro transcription (IVT) and plasmid DNA linearization.
• Knowledge in mRNA downstream methods for Tangential Flow Filtration (TFF) and multiple chromatography techniques such as dT Affinity, IEX, and RP-HPLC.
• Experience operating automated chromatography systems (ÄKTA Avant/Pure) and filtration skids (Repligen KrosFlow Kr2i).
• Comprehensive understanding of tech transfer activities around the production of mRNA drug substance
• Expertise in process scaling around mRNA production from bench scale to GMP manufacturing

Preferred Qualifications

• Experience with mRNA-LNP formulation and mixing technologies/equipment
• Ability to use statistical software such as JMP for Design of Experiments (DoE) and data analysis.
• Familiarity with GMP regulations, Quality by Design principles, and preparing regulatory filing documentation.

The budgeted range for this position is $105,000 - $145,000.This range is a good faith estimate of the expected salaryrange for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.