Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation.
Responsible for performing complex routine chemical analyses. This work is performed under the cGMP/FDA (Current Good Manufacturing Practice/Food and Drug Administration) guidelines. Initiates and executes independent analytical and systems improvement projects.
- Oversee, interpret results and perform analytical investigations for atypical data. Assist in the gathering of evidence or results. Write summary reports detailing the investigation.
- Write, review and revise SOPs, CAPAs and deviations and serve as a technical resource to ensure compliance with compendial documents.
- With minimal assistance from management, author, execute and interpret chemical experiments, analytical method development and method validation efforts as necessary.
- Properly record all data results on appropriate documents and in electronic files, including immediate communication of issues to management, both in own work and others in the lab.
- Train other analysts in overall laboratory processes/systems and in general and complex assays. Review and interpret the work of other analysts.
- Follow Standard Operating Procedures (SOPs) to obtain accurate results.
- Coordinate with vendors and other analysts to perform routine calibration and preventive maintenance of laboratory equipment.
- Ensure that the work area is maintained in a clean condition and free from clutter. Assist in reporting obstacles that hinder the cleanliness of the laboratory.
- Able to work overtime or extended hours as needed.
- Participate in and follow departmental training, SOP, procedure and protocol documentation as required.
- Perform other duties as assigned