Senior Manager Science & Technology (Analytics & Testing) (m/f/d)
Core
Lead the Analytical Innovation & Testing team to drive method development, validation, transfer, and product testing for medical devices and drug-device combination products.
Role type
Senior Manager, Head of Medical Device Laboratory
Builds
Functional and mechanical test methods, design verification, container closure integrity, and stability testing for clinical trials and commercial products.
Domain
Pharmaceutical industry, medical device development, regulatory compliance (GMP, ISO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People leadership, project and program planning, method development for combination products, GMP compliance, regulatory guidelines for drug-device products
Preferred skills
Materials science, process simulation, technical writing, waterfall model
Technologies
ISO standards, Pharmacopeia, GMP, AMBO §9
Responsibilities
Lead the Analytical Innovation & Testing team, plan and control project resources/schedules/budgets, oversee release of incoming materials and assembled products for clinical trials, act as Head of Quality Control, represent the team in internal and authorities' inspections
Seniority
Senior Manager, hands-on leadership
