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Senior mRNA Process Development Scientist
2 months ago
We are seeking a highly skilled and experienced mRNA Process Development Scientist/Engineer to join our dynamic team at Nava Therapeutics. As a key member of our R&D team, you will be responsible for developing, optimizing, and scaling up processes to produce mRNA-based therapeutics.
Key Responsibilities- Process Development:
- Design and execute experiments to develop and optimize mRNA synthesis and purification processes.
- Identify and troubleshoot process-related issues, implementing solutions to enhance product yield, purity, and consistency.
- Scale-up mRNA production processes from bench scale to pilot and commercial scales.
- Technical Expertise:
- Utilize advanced analytical techniques to characterize mRNA products and intermediates.
- Stay current with industry trends and advancements in mRNA technology and process development.
- Apply knowledge of biochemistry, molecular biology, and process engineering to optimize mRNA production.
- Documentation and Compliance:
- Prepare and maintain detailed documentation of process development activities, including experimental protocols, reports, and standard operating procedures (SOPs).
- Ensure all processes are compliant with regulatory requirements and industry standards (e.g., GMP, ICH guidelines).
- Support regulatory submissions by providing technical data and documentation.
- Collaboration and Communication:
- Work closely with cross-functional teams to transfer developed processes to manufacturing.
- Communicate findings and progress to internal stakeholders through presentations and reports.
- Mentor junior staff and provide technical guidance as needed.
- Education:
- Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or a related field, with 3+ years of relevant experience.
- OR Master's degree with 8+ years of relevant experience.
- Experience:
- Proven experience in mRNA process development, including high-yield synthesis, purification, and analytics.
- Familiarity with mRNA capping, tailing, and modification techniques.
- Experience with scale-up and tech transfer to manufacturing is highly desirable.
- Familiarity with GMP guidelines and regulatory requirements for mRNA-based products.
- Skills:
- Strong problem-solving skills with the ability to troubleshoot complex processes.
- Excellent laboratory skills, including direct experience with qPCR, ELISA, Nanoorange, chromatographic techniques, and other analytical methods.
- Strong communication skills, both written and verbal, with the ability to present data clearly and effectively.
- Ability to work independently as well as part of a team.
- Experience with lipid nanoparticle formulation and characterization.
- Previous experience in a biotech or pharmaceutical industry setting.
