Senior Scientist Process

Johnson & Johnson Johnson & Johnson · Pharma · Schaffhausen, Switzerland

Senior Scientist role focused on process development for fill/finish manufacturing of biotherapeutic products within Johnson & Johnson's Innovative Medicine division. The position requires a strong understanding of physical, chemical, and biological principles governing process and product performance, scale-up, and adherence to regulatory requirements. Responsibilities include designing experiments, developing fundamental understanding of unit operations, evaluating manufacturing processes, and collaborating with cross-functional teams.

What you'd actually do

  1. Act as program/project PD Lead and Support the design of laboratory experiments in collaboration with project teams.
  2. Uses underlying physical, chemical, and biological principles to identify the mechanisms and kinetics governing process and product performance and scale up and achieve target process performance at all scales.
  3. Develops fundamental understanding of large molecule parenteral process unit operations on physical/chemical/biological product quality attributes, specifically freeze/thaw, mixing, filtration, filling process steps and PAT based experiments.
  4. Develops and uses lab based “scale-down” models to evaluate process parameters and ranges and builds knowledge of “scale up” of unit operations to confirm or modify understanding of critical and key parameters.
  5. Evaluates the suitability of manufacturing processes to existing product, process, and materials platforms and vice versa.

Skills

Required

  • Master Degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 3 years of experience OR a PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with up to 3 years of experience
  • Demonstrated competency and experience in biologics drug product development within the biopharmaceutical industry
  • Knowledge of drug substance and/or drug product process
  • Knowledge and applied experience of biopharmaceutical process design, technology transfer and drug product fill/finish operations
  • Ability to collaborate with cross functional teams

Nice to have

  • Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices
  • Analytical Reasoning
  • Biochemistry
  • Chemistry
  • Manufacturing, and Control (CMC)
  • Coaching
  • Consulting
  • Critical Thinking
  • Drug Discovery Development
  • Emerging Technologies
  • Molecular Diagnostics
  • Pharmacogenetics
  • Pharmacovigilance
  • Process Improvements
  • Quality Assurance (QA)
  • Relationship Building
  • Research Documents
  • Scientific Research
  • Technologically Savvy

What the JD emphasized

  • biologics drug product development within the biopharmaceutical industry is required
  • Knowledge and applied experience of biopharmaceutical process design, technology transfer and drug product fill/finish operations is a must
  • Ability to collaborate with cross functional teams is a must