Senior Scientist – Bioanalytical Laboratory Report Specialist
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
Qualifications
- 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
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Science and Research
Industries: Biotechnology Research and Research Services
Location: Philadelphia, PA