Job Description

Responsibilities

· Prepare reagents, standards, and control samples

· 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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