Functions as an independent Study Director and Principal Investigator
• Design, write, review and edit as necessary, study plans, amendments and study schedules that define and plan all activities for bioanalytical validations.
• Validation (GLP) of quantitative assays for the analysis of pharmaceutical products in biological matrices by LC-MS/MS.
• Principal Investigator for analysis of incurred study samples, requiring interaction and co-ordination with the Study Director.
• Oversee and co-ordinate all aspects of laboratory work, preparation of GLP driving documents and instructions for the technical group, and ensure that projects are performed according to SOP and GLP.
• Project management and Client interaction.
• Prepare as necessary draft or final reports that document all laboratory procedures and results.
• Method troubleshooting, as required.
The following are minimum requirements related to the Study Director/Principal Investigator position:
- Possess a B.Sc. or M.Sc. in Biochemistry, Chemistry or related analytical discipline
- Three years of experience in conducting quantitative bioanalytical mass spectrometry.
- Is organized, responsible, dynamic and self-motivated.
- Has a good knowledge of GLP.
- Good problem solving skills.
- Possess excellent communication, interpersonal and teamwork abilities.
- Has a good knowledge of Microsoft Word and Excel, ThermoFisher Watson LIMS and Sciex Analyst software
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.Apply Now