Job Description:
2 ops for pharmaceutical method development and validation support, working in the MTAC laboratory and funded by WM eXact TDP.
Experience with HPLC, GC, Empower, and MassHunter strongly preferred.
Job Purpose:
- This role is on-site in Maple Grove, MN.
- Provides analytical pharmaceutical development and analysis support to an analytical pharma team within a large materials science and analytical chemistry laboratory.
- Collaborates with R&D on development, validation, and transfer of new analytical methods and technologies to be implemented in a QC Lab.
Key Responsibilities:
- Provide hands-on support and ownership of method development activities for pharmaceutical analysis methods, including OOS investigations, experimental plans, and technical reports.
- Assists with development and validation of new methods/technologies for pharmaceutical analysis, using liquid chromatography, gas chromatography, and other analytical techniques as needed.
- Writes method transfer/validation protocols/reports.
- Executes method transfer and validation studies.
- Trains QC technicians on new methods/technologies.
- Sources new equipment, performs qualifications, and writes protocols, final reports, SOP's and technical documents for new equipment.
- May lead special projects, write new procedures and work plans for tests and give guidance in specialized analytical technologies.
- As needed, advises and directs other analytical technicians on work assignments and training.
- May evaluate new analytical technologies and determine application and added value for BSC operations.
Quality Systems Duties and Responsibilities:
- Build Quality in all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
- 2 - 4 Years with BS or 0 - 2 Years with MS
- Experience in cGMP/GLP laboratory
Additional Job Specific Requirements:
- Experience with Waters Empower
- Experience with MassHunter
- HPLC and/or GC experience