Scientist I/II, LNP Process Development

Summary of Position:

We are seeking a highly motivated and scientifically rigorous individual to join our LNP Process Development team. The incumbent will be responsible for developing, optimizing, and scaling up processes for the production of lipid nanoparticles for ReCode’s clinical stage programs. This role involves working closely with cross-functional teams (formulations, analytical, mRNA process, supply chain, and quality) to ensure efficient and scalable manufacturing processes that meet quality and regulatory standards. The ideal candidate will be proactive, enthusiastic, and show a passion for LNP process development.

Job Responsibilities:

• Develop and optimize processes to enable robust lipid nanoparticle manufacturing processes.
• Design and conduct experiments to evaluate process parameters and ensure batch to batch reproducibility.
• Scale up laboratory processes to pilot and production scales while ensuring process consistency and product quality.
• Troubleshoot and resolve issues related to process performance and product yield.
• Prepare detailed reports and documentation for process development activities, including process flow diagrams, experimental protocols, and results.
• Maintain accurate and up-to-date records in compliance with regulatory guidelines.
• Provide technical support and guidance to manufacturing teams during scale-up and production phases.
• Facilitate technology transfer from ReCode to external manufacturing partners, including the preparation of documentation and training of manufacturing personnel.
• Author or review batch records to support external or internal manufacturing campaigns
• Ensure accuracy, completeness, and compliance of batch record with regulatory standards and internal procedures.
• Provide hands on support for clinical manufacturing campaigns.
• Generate and review reports on manufacturing performance, including process efficiency, yield, and quality metrics.
• On a need basis support review of regulatory submissions related to LNP products, including investigational new drug (IND) applications
• Identify opportunities for process improvements and implement changes to enhance efficiency and product quality.
• Provide technical mentorship to junior scientists/engineers in various aspects of parenteral drug product development and aseptic processing
• Stay current with industry trends and advancements in lipid nanoparticle technology.

Required Skills & Qualifications:

• PhD in chemical engineering, bioengineering, pharmaceutical sciences, chemistry or a related discipline with 0-3 years of relevant industry experience. Comparatively, a candidate possessing an MS in chemical engineering, bioengineering, pharmaceutical sciences, chemistry or a related discipline with 6-8+ years of relevant experience will be considered.
• Experienced in manufacturing unit operations such as high energy mixing, TFF, fill/finish etc
• Experience with process optimization, scale-up, and technology transfer.
• Previous experience in a regulated biopharmaceutical environment.
• Excellent problem-solving skills, attention to detail, and ability to work effectively both independently and as part of a team.
• Strong communication skills, both written and verbal.
• Rigorous troubleshooting, and problem-solving skills
• Works independently as well as collaboratively within groups and interdisciplinary teams
• Desire to work in a fast-paced environment

Preferred Skills & Qualifications:

• Proven experience in complex manufacturing processes, preferably with viral or non-viral vector systems, liposomal, lipid-based products or similar complex biopharmaceutical products.
• Strong understanding of LNP formulation, production, and characterization techniques. Experience with advanced manufacturing technologies and process automation.
• Familiarity with data analysis tools and statistical methods such as JMP
• Experience and/or knowledge in pre-formulation, formulation and process development, Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs).

Salary Range: *$115,000 - $135,000

*Please note that for remote positions, salary may be adjusted for cost of living