Study Director II - Particulate Testing Lab
Core
Lead scientific and operational execution of medical device and healthcare testing studies from initiation to final reporting, ensuring regulatory compliance and customer satisfaction.
Role type
Senior Study Director (Particulate Testing Lab)
Builds
Scientific study reports, validated test results, and technical documentation for medical device and pharmaceutical clients.
Domain
Life Sciences / Medical Device Testing / Sterility Assurance
Deliverable
client delivery
Required skills
Scientific leadership, project management, technical writing, regulatory compliance, stakeholder management, risk management, data analysis, test method development, quality systems oversight
Preferred skills
Medical device testing, sterility assurance, microbiology, biocompatibility, biomaterials, pharmaceutical sciences, validation & verification, GLP/GMP/ISO experience
Technologies
Laboratory Information Management Systems (LIMS), analytical chemistry equipment, sterilization irradiators
Responsibilities
Direct technical execution of studies from initiation through final report issuance; Review, interpret, and communicate study results; Collaborate on test method development and validations; Manage multiple studies simultaneously while maintaining quality; Ensure studies comply with regulatory and laboratory requirements; Provide guidance and mentorship to laboratory staff
Seniority
Senior, hands-on IC with leadership responsibilities