Scientist I, Parenteral Drug Product Development
$103k - $133.75kBiogen Inc
Biogen seeks a Scientist I/II for parenteral formulation and drug product development supporting its pipeline programs. The role involves formulation design, process development, manufacturing support, and regulatory documentation within a collaborative matrix environment.
Responsibilities
- Design and execute formulation and process development studies for preclinical, clinical, and commercial drug product programs
- Develop sterile parenteral drug products including formulation optimization, manufacturing process development, and technology transfer
- Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities
- Collaborate with cross-functional teams including drug substance, analytical, manufacturing, quality, and regulatory groups
- Author technical reports, development protocols, and CMC documentation supporting regulatory submissions
Requirements
- Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, or Analytical Chemistry; or M.S. with 2-4+ years experience; or B.S. with 4-6+ years experience
- Demonstrated experience in pharmaceutical drug product development, preferably sterile parenteral formulations
- Knowledge of drug product manufacturing operations including mixing, sterile filtration, aseptic filling, and lyophilization
- Experience planning and executing laboratory experiments, analyzing data, and drawing scientific conclusions
- Proficiency with analytical and characterization techniques for sterile drug products
- Experience authoring technical reports, protocols, and CMC documentation; regulatory submission exposure preferred
- Ability to work independently and collaborate effectively across multidisciplinary teams
Compensation: $103,000-$133,750 base
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