This role is responsible for defining the strategy and leading the implementation of end-to-end analytical control strategies across the product lifecycle
Job Summary
This role is responsible for defining the strategy and leading the implementation of end-to-end analytical control strategies across the product lifecycle.
The position requires leading cross-functional teams to coordinate complex analytical investigations and drive corrective actions using scientific principles.
Candidates must have significant experience working with regulatory agencies for IND/BLA submissions in the (Bio)Therapeutics or vaccines sector.
Matching Summary
This role is responsible for defining the strategy and leading the implementation of end-to-end analytical control strategies across the product lifecycle.
Skills & Requirements
Must-have
Analytical technologies development
Method qualification and validation
New Product Introduction experience
Regulatory agency interaction IND/BLA
GMP standards compliance
Matrix leadership capabilities
Nice-to-have
Quality by Design knowledge
Technology transfer expertise
Root cause analysis leadership
Complex problem solving skills
ICH Q7 Q8 Q9 Q10 familiarity
Key Requirements
PhD required with 10+ years experience
MS degree with 12+ years experience
BS degree with 15+ years experience
Degree in Biochemistry, Biology, Chemistry, or Pharmacy