Scientist, Downstream mRNA Purification Process Development

Highly Competitive Salary
  1. Permanent
  2. Biological Sciences, Bioprocessing, Molecular Biology
  3. United States
Woburn, USA
Posting date: 16 Mar 2021
SC.MR.35228

Proclinical is urgently recruiting for a Scientist of Downstream mRNA Purification Process Development with a global pharmaceutical company located in Woburn, MA. As the Downstream mRNA Purification Process Development Scientist, you will have the experience leading the efforts of mRNA downstream process development from early-stage process design to late stage GMP process implementation.

Job Responsibilities:

  • Apply deep knowledge in chromatography, solid-liquid separations, clarification, and tangential flow filtration to lead scalable mRNA downstream process development
  • Lead screening, optimization, and scale-up efforts on plasmid isoform separation and mRNA purification after IVT synthesis and enzymatic modifications.
  • Design and execute DOE studies & high-throughput screen for purification process improvements and advancements including parameter optimization, scale-up, process window determination and process capability evaluation
  • Lead downstream process tech transfer to pilot plant and GMP facility via drafting SOPs, oversee scale-up, verification & validation activities
  • Support the development of in-process assay and final product release testing to evaluate mRNA purity profile
  • Assist in the development of automated mRNA purification system to support high-speed downstream process screen
  • Work closely with cross-functional teams including CMC scientists to develop mRNA production strategies to meet ambitious project timeline.
  • Communicate effectively with regular verbal and formal updates to project teams and management.
  • Maintain necessary documents including laboratory notebooks, process development reports, technical transfer records, and process related documents.
  • Build and promote the company's value and culture, result oriented, work with can-do attitude, team player mentality, constantly inject positive energy into the working environment.

Skills and Requirements:

  • Degree in Biotechnology, Bioengineering, or a related scientific field. BS with 10+ years of directly related experience, MS with 8+ years of directly related experience, or PhD with 4+ years (preferred) of directly related experience.
  • Strong understanding of purification of biologics, specifically mRNA, including process scale-up. A proven track record of purifying multiple drug modalities is strongly preferred.
  • Strong hands-on experience with a wide range of purification techniques for large nucleic acid molecules including affinity capture, ion exchange, hydrophobic interactions, is a must
  • Strong hands-on experience with a wide range of downstream techniques including Depth filtration, UF/DF, TFF, is highly desired
  • Proficient with ÄKTA systems and UNICORN control software
  • Experience in high-throughput screen and DOE statistical tools for process development techniques is highly desired
  • Experience with tech Transfer of manufacturing processes is a strong plus
  • Experience in cGMP requirements for process development is a strong plus.
  • Experience in standard analytical technologies for biologics including HPLC, agarose gel electrophoresis, capillary electrophoresis, qPCR, ELISA is a plus.
  • Experience with automated systems and programming is a plus
  • Experience in author & technical review on supporting documentations for CMC and regulatory filings is a plus.
  • An ability to work independently, meet deadlines and prioritize work effectively. Must be able to thrive and deliver results on goals in a fast-paced, dynamic and highly multi-tasking environment.
  • Demonstrated capabilities to implement advance technologies and persist to successful outcomes.
  • Experience in large-scale process of mRNA automation synthesis and purification is highly desired

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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