Engineer II, Drug Product Development

Moderna is a leading company in mRNA technology, focused on changing the future of medicine. They are seeking an Engineer II in Drug Product Development to support the development of sterile drug product processes and products for clinical and commercial supply.

Responsibilities:

• Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, transport 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
• Perform a range of routine and non-routine characterization techniques, including opacity testing, microscopy, particle sizing etc
• Develop processes suitable to ensure long-term stability of vialed drug product
• 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:

• Masters or Bachelor's Degree in Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above
• 0 – 2 years post Master's Degree or at least 2 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
• Ability to travel up to 20%
• Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
• Experience with nanoparticle formulation technology
• Knowledge of GMP compliance