Senior Scientist, Parenteral Drug Product Development Job at Biogen, Cambridge, MA

  • Biogen
  • Cambridge, MA

Job Description

Biogen seeks a Senior Scientist for parenteral drug product development in Cambridge, MA. The role involves formulation and process development for sterile parenteral drugs across preclinical through commercial stages, collaborating across technical functions in a matrix environment.

Responsibilities

  • Design and execute formulation and process development studies from preclinical through commercial stages
  • Lead sterile parenteral drug product development including formulation optimization and manufacturing process design
  • Provide technical support during GMP manufacturing, process validation, and commercial campaigns
  • Develop strategies for container closure systems and support equipment qualification and compatibility assessment
  • Prepare technical reports, development protocols, validation documents, and regulatory submission materials

Requirements

  • Ph.D. in Chemical Engineering, Pharmaceutics, or related field with 4+ years pharma/biotech experience
  • Demonstrated expertise in sterile parenteral formulation and drug product development
  • Strong knowledge of manufacturing processes including sterile filtration, aseptic filling, and lyophilization
  • Experience with process validation, PPQ, technology transfer, and GMP guidelines
  • Ability to lead technical initiatives independently and collaborate across multidisciplinary teams
  • Experience authoring regulatory submissions and health authority responses
  • Background with oligonucleotide, peptide, antibody, or conjugated therapeutic formulations preferred

Compensation: $138,000–$184,500 base

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