Associate Director, mRNA & IVT Process Development

Proclinical is seeking a Principal Scientist or Associate Director, mRNA & IVT Process Development to join a new mRNA therapeutics and vaccines biotech with ambitions to develop mRNA medicines for global markets. With a strong pipeline of preclinical programs, this could be a great opportunity to gain experience in programs across a range of disease spaces and help progress multiple candidates into the clinical.

Job Responsibilities:

• Build up a high-performance process development team to develop in-house mRNA production capabilities, with an emphasis on establishing a scalable/transferable process for producing high-purity material.
• Use DOE principle to design and execute process optimization and advancements including plasmid linearization, mRNA IVT synthesis, post modifications and purification.
• Support the development and implementation of automated workflows for internal high-throughput & high-quality mRNA production.
• Support the development of robust physicochemical, chromatographic, and molecular and cell-based assays for in-process controls and final product release testing.
• Author and review protocols and technical reports to support drug substance and drug product clinical development.
• Proactively evaluate new technologies, stay up-to-date with current literature, and implement new features and functionalities into the mRNA platform.
• Responsible for mentoring a team of scientists in the laboratory and supporting the design, execution and interpretation of experimental studies.
• Collaborate cross-functionally with research, analytics, quality, and manufacturing team to attribute the delivery of project timeline.
• Communicate effectively with regular verbal and formal updates to project teams and management.

Skills and Requirements:

• PhD/MS Degree in Molecular Biology, Molecular Medicine, Genetics, Biotechnology, Bioengineering, or a related scientific field with 5+ years of directly related experience in industrial settings.
• Excellent scientific understanding of IVT and other enzymatic reactions for mRNA preparation as well as mRNA purification
• Advanced hands-on experience in plasmid preparation, in vitro transcription, mRNA purification (HPLC, chromatography and filtrations).
• Hands-on experience in standard analytical methods for characterization of biologics, including HPLC, agarose gel electrophoresis, capillary electrophoresis, qPCR, and ELISA.
• Experience in high-throughput screen and DOE statistical tools for process development is a strong plus.
• Experience in automation workflow for mRNA preparation and analytics is a strong plus.
• Knowledge of GMP/ICH/FDA regulations and experience in authoring and reviewing CMC regulatory documentation is a plus.
• An ability to work independently, meet deadlines and prioritize work effectively. Must be able to sthrive and deliver results on goals in a fast-paced, dynamic and highly multi-tasking environment.
• Demonstrated enthusiasm and capabilities to implement advance technologies and persist to successful outcomes.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 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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