Senior Scientist
Avantor · Bridgewater, NJ · 2 wk ago
Analyst$108k–$173k/yrFull-time
About the Role
Avantor is seeking a highly skilled and motivated Senior Scientist with a strong background in mRNA Technology & Process Development to lead and support process development initiatives and manufacturing operations for excipients and reagents.
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.
Preferred Qualifications
- 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.
Benefits
- Comprehensive benefits package including medical, dental, and vision coverage.
- Wellness programs, health savings and flexible spending accounts.
- 401(k) plan with company match and employee stock purchase program.
- 11 paid holidays.
- 18 PTO days annually.
- Volunteer time off.
- 6 weeks of 100% paid parental leave (except in states that offer paid family leave).
Pay
The expected pre-tax pay for this position is $107,500.00 - $173,075.00. Actual pay may differ depending on relevant factors such as prior experience and geographic location.