Drug Product Development Engineer II: Aseptic & Scale-Up

RXinsider LTD.

Norwood (MA)

On-site

USD 74,000 - 118,000

Full time

10 days ago
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Benefits offered by this job

Health benefits
Well-being resources
Family planning benefits
Generous paid time off
Savings & investments

Job summary

Moderna in Norwood, MA is seeking a skilled individual to support sterile drug product development, including image development, process scale-up, and container-closure studies. You’ll work on aseptic fill/finish, DoE-driven experiments, and collaboration with the Pilot organization to advance formulation and manufacturing processes.

The role emphasizes rigorous data reporting, effective communication, and cross-functional teamwork in a fast-paced biotech environment.

Qualifications

  • Education: Masters or Bachelor’s Degree in Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or related fields.
  • 0–2 years post Master’s Degree or at least 2 years post Bachelor’s Degree.
  • Exceptional laboratory skills in a dynamic environment.
  • Knowledge of DoE and data analysis.
  • Knowledge of nucleic acid chemistry and biology is a plus.
  • Preferred: BioPharma/Biopharma/Pharmaceutical/Biotechnology experience.
  • Preferred: Nanoparticle formulation technology.
  • Preferred: GMP compliance knowledge.
  • Ability to travel up to 20%.

Responsibilities

  • Conduct studies to support scale-up of drug product manufacturing (freeze/thaw, mixing, filling, filtration, lyophilization, transport).
  • 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 with Moderna’s Pilot organization, including toxicology fills stability fill operations.
  • Plan, organize and execute experiments (DoE where possible) – prepare study protocols and summarize development results with presentations and study reports.
  • Communicate and collaborate with analytical development to execute experiments and compile data.
  • Support manufacturing with studies for process trouble‑shooting and investigations.
  • Perform characterization techniques including opacity testing, microscopy, particle sizing.
  • Develop processes 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 formulation and process problems.

Skills

Exceptional laboratory skills
DoE (design of experiments)
Nucleic acid chemistry knowledge
GMP compliance knowledge
Travel up to 20%

Education

Masters or Bachelor’s in Chemical Engineering
Biochemical or Biomedical Engineering
Pharmaceutical Sciences

Tools

Nanoparticle formulation technology

Job description

Moderna in Norwood, MA is seeking a skilled individual to support sterile drug product development, including image development, process scale-up, and container-closure studies. You’ll work on aseptic fill/finish, DoE-driven experiments, and collaboration with the Pilot organization to advance formulation and manufacturing processes.

The role emphasizes rigorous data reporting, effective communication, and cross-functional teamwork in a fast-paced biotech environment.

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