Study Director - LCMS
SGS North America Inc.

Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

The Study Director - Liquid Chromatography Mass Spectrometry (LCMS), is responsible for scientific, administrative, regulatory and project management for clinical and pre-clinical bioanalytical studies. Training and mentoring of bioanalytical staff.

• Oversight of the management of studies to ensure timelines are firstly set appropriately taking into account company and external stakeholder requirements, and once set, ensure timelines are achieved.
• Communicate effectively with external stakeholders (i.e. clients, CROs).
• Communicate with internal stakeholders (i.e. operations, QA, management) to ensure project progression.
• Ensure the scientific integrity and regulatory compliance of study data by (at minimum) the review of all runs.
• Lead of troubleshooting of scientific issues by liaising with appropriate groups including R&D, operations, management.
• Coordinate with operational groups to ensure operational progression of studies.
• Oversight of financial milestones and ensure out of scope work is identified and escalated appropriately.
• Develop and maintain strong relationships across the department in order to provide and receive guidance, feedback and support.
• Liaise with R&D to ensure smooth transition of methods into validation.

• Bachelors Degree in a scientific or laboratory based field or equivalent experience
• 7 years' experience in regulated Bio-analysis, ideally in a pharmaceutical or CRO environment.
• 3 years' experience as a Study Director in regulated bio-analysis.