Study Director - LCMS
SGS North America Inc.

Company Description

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected 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.
• Knowledge and experience with The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) M10 guidance
• 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.
• Position is located on-site at 8 Executive Dr, Hudson, NH 03051, USA