Job Description:
Independently design and develop methods, and complete complex lab work, sample analysis, validation, and method development
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 or
- 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
- Knowledge of and experience in a regulatory environment