Solid experience in a few of the area's listed below is needed to succeed in this role:
- LCMS
- Bioanalysis
- Small molecule and/ or large molecule
- Oligonucleotides
- Protein peptides- quantitative experience
- GxP including GOP & GCP
- Method development & sample analysis using LCMS
Responsibilities:
· Prepare reagents, standards, and control samples
· Analyze samples using various techniques specific to department
· Perform complex method development with limited supervision
· Perform method validation or qualification
· Operate analytical equipment
· Lead troubleshooting activities; assays and equipment
· Maintain analytical equipment
· Review, evaluate, and interpret data results
· Draft and present posters/presentations
· Train and mentor lower level Scientists
· Collaborate with clients and vendors
· Ensure lab area is clean and inspection ready at all times
· Remove lab waste
· Record tasks in accordance with Good Documentation Practices (GDP)
· Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11
· Follow applicable SOPs and procedural documents
· Other tasks as assigned
Qualifications & Education:
- BA/BS or higher with 5 years experience working LCMS at a CRO or pharma/ life sciences company
- PhD in relevant field with two years experience working in LCMS at a CRO or pharma/ life sciences company
- Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
- Able to independently perform complex lab work
- Able to work in a regulated environment
- Able to work effectively and contribute within a team
- Able to work with computer systems
- Able to document clearly
- Knowledge of and experience in a regulatory environment