Senior Scientist – Process Development

Avantor•Bridgewater, NJ

2d•Onsite

About The Position

Under limited supervision, develop and implement solutions for customers based on our products and services through close collaboration with customers and other innovation associates/scientists. Identify and develop innovative applications for a range of products to solve specific customer issues by planning and executing hands on studies at internal and customer laboratories.

Requirements

Ph.D. in Molecular Biology, Biochemistry, Bioengineering, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field (required).
Minimum of 5+ years of relevant industry experience in mRNA, RNA, nucleic acid, biologics, or pharmaceutical process development.
Doctoral or relevant academic experience may be considered equivalent to industry experience.
Strong understanding of mRNA process development, including DNA template generation, in vitro transcription (IVT), enzymatic processing, purification, and analytical characterization.
Hands-on experience with nucleic acid process development, molecular biology techniques, and scalable manufacturing processes.
Knowledge of process development principles including DOE, QbD, process characterization, scale-up, risk assessment, and CPP/CQA relationships.
Experience troubleshooting complex technical challenges, interpreting multidisciplinary data, and developing data-driven solutions.
Excellent technical writing, presentation, project leadership, and cross-functional communication skills.

Nice To Haves

End-to-end mRNA development experience from DNA template preparation through purified mRNA and formulation interface.
Experience with IVT, capping/polyadenylation, chromatography, TFF/UF-DF, process scale-up, technology transfer, or GMP manufacturing support.
Familiarity with high-throughput automation, continuous manufacturing, process intensification, PAT, or advanced manufacturing technologies.
Experience with mRNA analytical techniques such as HPLC/UPLC, LC-MS, CE, qPCR/ ddPCR, Bioanalyzer/ TapeStation, sequencing, or impurity analysis.
Experience applying DOE, QbD, JMP, Minitab, Python, R, or related statistical and data-analysis tools.
Exposure to GMP/GLP environments, regulatory documentation, method qualification, validation, or technology transfer activities.
Experience evaluating emerging technologies, vendors, CDMOs, external collaborations, or technical due diligence opportunities.

Responsibilities

Design, develop, and optimize end-to-end mRNA manufacturing processes, including DNA template generation, IVT, enzymatic processing, purification, buffer exchange, and formulation interfaces.
Develop robust and scalable workflows to improve mRNA yield, purity, quality, process robustness, and manufacturability.
Apply DOE, QbD, risk assessment, and statistical tools to build process understanding and establish relationships between process parameters and product quality attributes.
Collaborate with Analytical Development to characterize mRNA identity, integrity, purity, potency-related attributes, and process impurities.
Troubleshoot process and product-quality challenges using scientific and data-driven approaches, including root cause analysis and risk mitigation.
Author technical reports, development summaries, risk assessments, SOPs, study protocols, and regulatory-support documentation.
Evaluate and demonstrate emerging technologies including synthetic DNA, novel purification approaches, automation, process intensification, and continuous manufacturing concepts.
Support process characterization, control strategy development, and implementation of CPPs, CQAs, in-process controls, and process monitoring strategies.
Collaborate with manufacturing, quality, analytical, formulation, and regulatory teams to ensure successful process transfer and commercial readiness.
Participate in deviation investigations, change controls, root cause analyses, and continuous improvement initiatives.
Support GMP documentation activities including batch records, SOPs, process transfer packages, and validation-related documentation.
Assess external technologies, vendors, CDMOs, and strategic collaboration opportunities through proof-of-concept studies, technical due diligence, and workflow integration assessments.
Present technical findings, recommendations, and development strategies to project teams, cross-functional stakeholders, and senior leadership.
Mentor junior scientists and contribute to a culture of scientific excellence, innovation, safety, and operational rigor.