Scientist, Process Development

Posted 4 Days Ago
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Waltham, MA, USA
In-Office
105K-145K Annually
Senior level
Biotech
The Role
Lead development, optimization, and scale-up of mRNA production and purification processes. Characterize mRNA using electrophoresis, spectrophotometry, and HPLC/UPLC. Support tech transfer, collaborate with cross-functional teams, prepare SOPs and technical documents, and assist business development for client proposals.
Summary Generated by Built In

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 salary range 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.

Skills Required

  • BS/MS in Microbiology, Bioengineering, Biochemistry, or related discipline
  • 8+ years relevant experience with a minimum of 4 years working with mRNA-based therapeutics
  • Hands-on mRNA processing experience including in-vitro transcription (IVT) and plasmid DNA linearization
  • Experience with mRNA downstream methods such as Tangential Flow Filtration (TFF) and chromatography techniques (dT affinity, IEX, RP-HPLC)
  • Experience operating automated chromatography systems (ÄKTA Avant/Pure) and filtration skids (Repligen KrosFlow Kr2i)
  • Ability to characterize mRNA using electrophoresis, spectrophotometry, and HPLC/UPLC
  • Comprehensive understanding of tech transfer activities for mRNA drug substance production
  • Expertise in scaling mRNA production from bench scale to GMP manufacturing
  • 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 regulatory filing documentation
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The Company
HQ: Cambridge, MA
379 Employees

What We Do

ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare. ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.

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