Analyze samples using various techniques specific to department
Independently design and develop methods
Perform method validation or qualification
Operate analytical equipment
Technical resource for 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
Collaborate across teams, departments, and sites
Evaluate and establish processes to improve quality and efficiency
Record tasks in accordance with Good Documentation Practices (GDP)
Knowledge of regulatory requirements; GLP, GCP, 21CFR Part 11
Follow applicable SOPs and procedural documents
Other tasks as assigned
Education, Experience & Skills Required
BA / BS or higher with 11-12 years lab experience; all experiences will be evaluated
PhD in relevant field with 3-5 years lab experience
Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
Able to independently develop and 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
Able to communicate clearly
Physical Demands
Must be able to sit at a desk for up to 6 hours per day
Walking and / or standing as required for the rest of the working day
Must be able to occasionally lift 15 lbs.; this includes lifting boxes, equipment, etc.
Bending or standing as necessary
The length of time of these tasks may vary from day to day and task to task
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Senior Scientist • Malvern, PA, US
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