The role involves leading the complete setup and validation of a new QC laboratory to support the commercialization of biological drug products
Job Summary
The role involves leading the complete setup and validation of a new QC laboratory to support the commercialization of biological drug products.
Candidates must establish robust GMP systems ensuring product quality, safety, and strict adherence to regulatory standards like FDA and EMA.
Roche fosters a culture of personal expression and open dialogue where employees are valued for their unique qualities in preventing and curing diseases.
Matching Summary
The role involves leading the complete setup and validation of a new QC laboratory to support the commercialization of biological drug products.
Skills & Requirements
Must-have
GMP system development and maintenance
Lab establishment and equipment qualification
Biologics analytical testing experience
Method validation and data integrity
Regulatory compliance with FDA/EMA
Nice-to-have
Cross-functional collaboration skills
Continuous improvement initiatives
Project risk management awareness
Stakeholder communication abilities
Key Requirements
Bachelor's degree in Pharmacy, Chemistry, or Biochemistry
Master's degree in Analytical Science of Biological Product
Minimum 4 years experience in biologics analytical testing