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Senior/Principal Scientist, mRNA Process Development

Company: Daley And Associates, LLC.
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Our client, an early-stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies, is currently seeking a highly motivated and innovative Scientist, Senior Scientist or Principal Scientist, mRNA Process Development to join their team. This person will be responsible for leading mRNA process development efforts spanning from process design to technology transfer. The ideal candidate will be looking to grow their leadership/management skills and be an integral part of the company and its research discovery efforts. The hours for this position will be 3:00pm - 9:00pm.

Responsibilities

  • Planning and execution of mRNA production and purification development activities appropriate for GMP manufacturing.
  • Lead screening, optimization, and scale-up efforts for enzymatic reactions, chromatographic separations, and filtration processes including microfiltration, ultrafiltration, diafiltration, and sterile filtration.
  • Lead technology transfer to manufacturing by performing risk assessments, generating/reviewing development reports, reviewing master batch records, and providing technical support.
  • Assist in development of robust physicochemical, chromatographic, molecular, and cell-based assays for support of in-process controls and final product release testing.
  • Lead studies for process improvements and advancements.
  • Author and/or contribute to the technical review of supporting documents, reports, and change controls, including CMC sections for regulatory filings.
  • Actively develop junior staff and serve as a mentor and advisor.
  • Conducting laboratory experiments, excellent documentation review and writing skills, and the flexibility to work on multiple projects as needed.
    Qualifications
    • B.S. with 6+ years of directly related industry experience, MS with 4+ years of directly related industry experience, or PhD with 3+ years of directly related industry experience. Degree emphasis in Biochemistry, Chemical Engineering, Molecular Biology, Bioengineering, Molecular Medicine, Genetics or related field preferred.
    • In-depth understanding of purification of biologics, specifically mRNA, including process scale-up. A proven track record of purifying multiple drug modalities is strongly preferred.
    • Experience with Technology Transfer of manufacturing processes
    • Understanding of nucleic acid chemistry, enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for mRNA.
    • Proficient with --KTA systems and UNICORN control software.
    • Experience with high-throughput process development techniques, automation platforms, and statistical design of experiments (DoE) strongly preferred.
    • Understanding of requirements for development of biologics including requirements for product comparability.
    • Experience working with vendors.
    • Availability to be able to work flexible hours/shifts required.
    • Track record of completing deliverables within specified timelines.
    • Knowledge of GMP/ICH/FDA regulations strongly preferred.
    • Independently motivated, detail oriented and good problem-solving ability.
    • Excellent organizational skills
    • Able to multi-task in an extremely fast-paced environment with changing priorities.
      If you are interested in this position, please send your resume to apowell@daleyaa.com

Keywords: Daley And Associates, LLC., Cambridge , Senior/Principal Scientist, mRNA Process Development, Other , Cambridge, Massachusetts

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