Engineer I, Drug Product Development

Moderna is a biotechnology company developing an mRNA technology platform and medicines. The Engineer I will support sterile drug product process and product development for clinical and future commercial supply, including scale-up, container development, aseptic fill/finish, packaging, experimentation, and process troubleshooting.

Responsibilities:

• Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, etc)
• Conduct studies to support the drug product container / package development (e.g. shipping stress studies, label permeation studies, leachable & extractable studies, etc.)
• Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes
• Provide support to drug product development activities executed in collaboration with Moderna’s Pilot organization, including toxicology fills stability fill operations
• Plan, organize and execute experiments (using DoE where possible) – prepare study protocols and summarize the development results with presentations and study reports
• Communicate and collaborate with various groups such as analytical development to execute experiments and compile data
• Support manufacturing with studies for process trouble-shooting and investigations
• Maintain an up-to-date ELN with good documentation practices
• Closely collaborate with multiple groups to generate innovative solutions to challenging formulation and process problems

Requirements:

• Education Qualifications - Masters or Bachelor's Degree in on one of the following fields: Chemical Engineering, Biochemical or Packaging Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above
• Relevant Experience: 0 – 2 years post Master's Degree or 0 – 4 years post Bachelor's Degree
• Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
• Knowledge of statistical design of experiments (DoE) and analysis
• Knowledge of nucleic acid chemistry and biology is a plus
• Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
• Experience with nanoparticle formulation technology
• Knowledge of GMP compliance