Company DescriptionWe 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 DescriptionThe 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.
Additional InformationSGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disabilityAll your information will be kept confidential according to EEO guidelines.
