Engineer II, Drug Product Development

The Role

We are seeking a highly skilled and motivated Individual, to work in a team developing Moderna’s sterile drug product processes and products that enable clinical and future commercial supply. The primary role for this position will be to support drug product development activities including: image development, process development and scale-up, container development and conditions of use studies. The incumbent will support the development of compositions, aseptic fill/finish unit operations through the development and use of scale-down models, process characterization studies etc.

Applicants should have relevant pharmaceutical sciences related experience with various aspects of drug product development. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.

The Role

We are seeking a highly skilled and motivated Individual, to work in a team developing Moderna’s sterile drug product processes and products that enable clinical and future commercial supply. The primary role for this position will be to support drug product development activities including: image development, process development and scale-up, container development and conditions of use studies. The incumbent will support the development of compositions, aseptic fill/finish unit operations through the development and use of scale-down models, process characterization studies etc.

Applicants should have relevant pharmaceutical sciences related experience with various aspects of drug product development. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.

Here’s What You’ll Do

• 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.

• Education Qualifications - Masters or Bachelor’s Degree in on one of the following fields:
  Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above.
• Relevant
  
  Experience:
  
  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
• Knowledge of nucleic acid chemistry and biology is a plus
• Preferred:
  Experience in Bio Pharma, Bio Pharmaceutical, Pharmaceutical, or Biotechnology industry
• Preferred:
  Experience with nanoparticle formulation technology
• Preferred:
  Knowledge of GMP compliance.
• Ability to travel up to 20%.

• Competitive…