Yuria-Pharm Corporation is an international pharmaceutical corporation, one of the most dynamic and fastest growing pharmaceutical manufacturers of Ukraine. The Corporation's strategic priority is the implementation of advanced technologies for the development and production of pharmaceutical and biopharmaceutical APIs and drugs based on them in order to provide patients with access to the highest quality infusion therapy, highly effective targeted therapy, therapeutic solutions for combating orphan diseases, and vaccine solutions.

The R&D center of the Corporation has established world-class R&D infrastructure, which allows to carry out a full range of research, development and pilot production of medicinal products based on small molecules, recombinant proteins and mRNA, which opens up unique opportunities for the scientific community to create solutions that can change the lives of millions of patients worldwide.

Corporate R&D center in Kyiv, Ukraine invites you to join our team as a Process Development Engineer working on the development of production/purification technologies for nucleic acid-based API.

Responsibilities:

• Design, planning and execution of purification process development campaigns for nucleic-acid-based API using various process chromatography and process filtration technics
• Design, development and validation of process analytics procedures, required for process performance evaluation.
• Purification of lab and pilot-scale batches of nucleic acid-based API to support internal research activities and preclinical/clinical programs
• Design of production-scale purification trains, production-scale equipment evaluation and configuration, equipment setup/integration, maintenance
• Preparation of documentation for regulatory submission as a part of M3 CTD dossier for a drug product.

Basic qualification:

• MS degree in biology, chemistry
• Year of total experience in one of the following:

1. academic research involving nucleic acid/protein purification
2. industrial internships/extracurricular projects involving hands-on experience with protein/nucleic acid purification by chromatography technics

• Language knowledge requirements: English (upper-intermediate).

Preferred skills and experience:

• PhD in biochemistry, biophysics, physical chemistry
• Hands-on experience with chromatography-based nucleic acids purification
• Practical experience with large scale (mg-quantity) nucleic acids (mRNA) synthesis/purification
• Firm background in molecular biology of RNA metabolism and expression in cells
• Practical experience with Cytiva(GE) AKTA-family chromatography systems operation and maintenance/basic understanding of circuits and electrical engineering
• Practical experience with the following analytical technics
• LC-MS/MS (nucleic acid analytics applications)
• CE/UV, CE/MS
• Blotting technics (Northern Blot, Western Blot)
• PCR/qPCR/dPCR
• NGS DNA sequencing (OxNano/Illumina)
• Spectrometry/Fluorimetry
• Practical understanding of DoE methodology, experience with the data processing tools, suitable for multivariate data analysis (ex Statfoft Statistica, SPSS)
• Practical experience with different hardware platforms for downstream process development (PreDictor plates, Robocolumns, Minicolumns), understanding of their scope of use
• Solid background in statistical concepts, applicable to life science research
• Practical experience with analytical method validation according to ICHQ2A guidelines, documentation of validation process in regulated environments (ISO 17025-certified facilities)
• Enzyme purification experiences using His-tag/StrepTag II affinity tagging
• Basic scripting/programming skills (Python is preferred)
• Demonstrated ability to drive complex projects to completion.

Special requirements:

• Self-motivation with strong skills for provisional and operational planning, multitasking
• The ability to adapt to work in a dynamic development environment
• Ability to work overtime to meet required deadlines
• The ability to work in a team and organize the work of teams
• Accurate record keeping and attention to details in records maintenance

We offer:

• A unique world-class integrated R&D platform, enabled with state-of-the-art infrastructure, that provides a full range of opportunities for the implementation of research programs of any complexity
• The opportunity to work on the most advanced bioprocess platform in Ukraine
• The possibility of participation in internships and professional development programs, publication of scientific works, patents.
• A comfortable corporate campus in Kyiv
• Lunches provided for employees of the laboratory complex
• Flexible work schedule with the possibility of shifting working hours.
• 30 days of paid vacation annually
• Employee special discounts program for the medicines and products of internal manufacturing.