Scientist, mRNA Process Development

Proclinical is seeking a highly motivated and innovative candidate to join a Biotech's mRNA process development (PD). The PD team focuses on envisioning, development, scale-up and validation of GMP mRNA manufacturing process, while produces high-quality mRNA to support research candidate evaluation by our early discovery team. The successful candidates will have the experience leading the efforts of mRNA process development from early-stage process design to late stage process technology transfer.

Responsibilities Including, But Not Limited To

• Apply deep knowledge in nucleic acid research to lead mRNA process platform development
• Lead screening, optimization, and scale-up efforts on enzymatic reaction and IVT synthesis including plasmid digestion, mRNA synthesis, nucleobase modifications and post-transcriptional modifications.
• Design and execute DOE studies & high-throughput screen for process improvements and advancements
• Support the development of automated mRNA production process to supply high-quality mRNA for lead candidate screen
• Support the development of robust physicochemical, chromatographic, and molecular and cell-based assays for in-process controls and final product release testing.
• 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 values and culture, result oriented, work with can-do attitude, team player mentality, constantly inject positive energy into the working environment.

Qualifications

• Degree in Molecular Biology, Genetics, Biotechnology, Bioengineering, or a related scientific field. BS with 10+ years of directly related experience, MS with 5+ years of directly related experience, or PhD with 2+ years (preferred) of directly related experience.
• Strong understanding of nucleic acid chemistry, enzymatic and chemical reactions, and mRNA process at bench and larger scales.
• Strong hands-on skills in nucleic acid handling and manipulation including plasmid preparation, in vitro transcription, purification, and cleanup is a must.
• Proficient in analytical technologies including HPLC, agarose gel electrophoresis, capillary electrophoresis, qPCR, ELISA is required.
• Experience in high-throughput screen and DOE statistical tools for process development techniques is desired.
• Experience with automated systems and programming is a strong plus
• Experience in author & technical review on supporting documentations for CMC and regulatory filings is a strong plus.
• Experience in cGMP requirements for early phase development 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 Marta Suazo at (+1) 347-960-4479 or m.suazo@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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