Who’s Who in the Company: Departmental Roles, Organization, and Communication

Many biotech companies are very small at start-up, and employees may “wear many hats” (i.e. work as members of multiple departments).

 

Research and Development

Responsible for discovering/developing a product with commercial value

  • Develop processes to make the product
  • Determine which raw materials and equipment are required
  • Develop a plan for production
  • Characterize the properties of the product
    1. Composition
    2. Effect, strength, potency, purity, safety
  • Product applications
  • Develop methods to test the product

 

Manufacturing

Responsible for making the product

  • Preparation of supporting materials
  • Operation of equipment and instrumentation
  • Monitoring processes
  • Implementing corrective actions
  • Routine calibration and maintenance of equipment

 

Quality Control (QC)

Responsible for testing the product to ensure its identity, safety, purity, and stability

  • Also responsible for testing raw materials used to make the product
  • Performs environmental monitoring within facility

 

Quality Assurance (QA)/Regulatory Affairs

Responsible for ensuring compliance with CGMP

  • Review and approve all documentation
  • Store, prepare, and issue documents
  • Oversee audit methods, results, systems, and processes
  • Training oversight
  • Vendor qualifications and inspection
  • Validation plans

QA has the ultimate authority to release or reject both raw materials and product lots.