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.
Qualifications
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
