Experienced Scientist I

Johnson & Johnson Johnson & Johnson · Pharma · Malvern, PA +1

Scientist role focused on raw material characterization, qualification, and investigations for Cell and Gene Therapy (CGT) in a biopharmaceutical R&D setting. Involves collaboration with CMOs and internal teams, interpretation of regulatory guidance, and authoring regulatory documents. Primarily lab-based.

What you'd actually do

  1. Perform lab studies to support raw materials for CGT, focusing on characterization, qualification, and investigations (>50% lab-based work).
  2. Collaborate with CMOs to define appropriate controls for raw material qualification and support supplier and material qualification processes.
  3. Partner with API Protein, API CGT, and Drug Product development teams to define relevant material selection, assessments, and control strategies.
  4. Collaborate with CMC teams to support both internal manufacturing sites and external CMOs.
  5. Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality standards, and scientific principles.

Skills

Required

  • Bachelor degree in Medicinal Chemistry, Materials Science, Biomedical Engineering, Chemical Engineering, Pharmacy, or related field
  • 2 years of experience in the job offered or in an Experienced Scientist I-related occupation

What the JD emphasized

  • raw materials for CGT
  • characterization
  • qualification
  • investigations
  • GMP
  • regulatory guidance