Sterile Drug Product Development Engineer II

Moderna; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Job summary

Moderna is seeking a highly skilled scientist to join a team developing sterile drug product processes and products for clinical and future commercial supply. The role supports drug product development activities including image development, process development and scale-up, container development and use studies.

You will plan, organize and execute experiments (DoE when possible), summarize development results in study reports, and communicate with analytical development, Pilot organization, and

Qualifications

• Masters or Bachelor’s Degree in relevant fields such as Chemical Engineering, Biochemical/Biomedical Engineering, Pharmaceutical Sciences, Materials Science.
• 0–2 years post Master’s Degree or at least 2 years post Bachelor’s Degree.
• Exceptional laboratory skills and attention to detail in a dynamic environment.
• Knowledge of statistical design of experiments (DoE) and analysis.
• Knowledge of nucleic acid chemistry and biology is a plus.

Responsibilities

• Conduct studies to support scale-up and tech transfer of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, transport).
• Develop protocols to evaluate compatibility of drug product with processing materials, container closure components, and sterilization processes.
• Provide support to drug product development activities with the Pilot organization, including toxicology fills and stability fill operations.
• Plan, organize and execute experiments (DoE where possible) – prepare study protocols and summarize results with presentations and study reports.
• Communicate and collaborate with analytical development to execute experiments and compile data.
• Support manufacturing with studies for process troubleshooting and investigations.
• Perform routine and non-routine characterization techniques (opacity testing, microscopy, particle sizing).
• Develop processes suitable to ensure long-term stability of vialed drug product.
• Maintain an up-to-date ELN with good documentation practices and collaborate across groups.

Skills

Laboratory skills

DoE knowledge

Nucleic acid chemistry knowledge

Education

Masters or Bachelor's degree in Chemical/ Biochemical/ Biomedical Engineering or Pharmaceutical Sciences

Job description

Moderna is seeking a highly skilled scientist to join a team developing sterile drug product processes and products for clinical and future commercial supply. The role supports drug product development activities including image development, process development and scale-up, container development and use studies.

You will plan, organize and execute experiments (DoE when possible), summarize development results in study reports, and communicate with analytical development, Pilot organization, and