Drug Product Development Engineer II: Sterile Fill/Finish & Scale-Up

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

Job summary

Moderna seeks an innovative professional to join a team developing sterile drug product processes for clinical and future commercial supply. You will support drug product development activities, scale-up, container development, and aseptic fill/finish operations using scale-down models and DoE-driven studies.

The role requires strong laboratory skills, DoE knowledge, and collaboration across analytical, toxicology, and manufacturing teams in a fast-paced, interdisciplinary setting.

Qualifications

• Exceptional laboratory skills with ability to work efficiently in a dynamic environment.
• Knowledge of statistical design of experiments (DoE) and analysis.
• Knowledge of nucleic acid chemistry and biology is a plus.
• Preferred: BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry experience.
• Preferred: GMP compliance knowledge.

Responsibilities

• Conduct studies to support scale-up of drug product manufacturing (freeze/thaw, mixing, filling, filtration, lyophilization, transport).
• Develop protocols to evaluate compatibility of drug product with processing materials, containers, and sterilization processes.
• Support drug product development activities with Moderna’s Pilot organization, including toxicology fills stability fills.
• Plan, organize and execute experiments (DoE where possible) and summarize results with presentations/reports.
• Collaborate with analytical development to execute experiments and compile data.
• Support manufacturing with studies for process troubleshooting and investigations.
• Perform characterization techniques (opacity testing, microscopy, particle sizing).
• Develop processes for long-term stability of vialed drug product.
• Maintain up-to-date ELN with good documentation practices.
• Collaborate across groups to generate formulations and process solutions.

Skills

Lab skills

DoE knowledge

Analytical mindset

GMP familiarity

Travel up to 20%

Education

Masters or Bachelor's in Chemical Eng./Biochemical/Biomedical Eng./Pharmaceutical Sciences

Job description

Moderna seeks an innovative professional to join a team developing sterile drug product processes for clinical and future commercial supply. You will support drug product development activities, scale-up, container development, and aseptic fill/finish operations using scale-down models and DoE-driven studies.

The role requires strong laboratory skills, DoE knowledge, and collaboration across analytical, toxicology, and manufacturing teams in a fast-paced, interdisciplinary setting.