Pine Lake Laboratories is a contract research organization providing analytical solutions to the pharmaceutical, biotech and medical device industries. We specialize in developing analytical methods to meet our client’s needs in the development and FDA registration of innovative new therapies and devices. We are FDA registered and inspected with a proven record of ensuring FDA compliance. Our areas of expertise include extractable and leachables testing, CMC analytical testing and analytical testing of combination products.
We are looking for an analytical chemist with GC-MS experience. The successful candidate will be able to work on multiple projects in a team environment.
- Independently perform GC and GC-MS approved methods.
- All work performed in compliance to FDA GMP regulations
- Develop and validate GC and GC-MS methods for the analysis of residual solvents in drug substances and volatile organic leachables in drug products.
- Identify unknown volatile and semi-volatile organic compounds by GC-MS.
- Participate in extractables and leachables studies.
- Troubleshoot and maintain instruments.
- Ensure all work is performed in GMP compliance.
- Record all experimental details, observations, data and results in a clear and timely manner
- Write analytical methods, protocols, reports, COAs and other documents
- Perform peer review of data generated by other scientists
- Ability to execute in a fast-paced, research driven and results oriented environment
- Bachelor’s degree in chemistry
- 5-8 years GC and GC-MS experience