PharMEDium Services, a division of AmerisourceBergen, is a growing outsource compounding organization servicing hospitals nationwide. Our growth now has encouraged our business to seek a Lead Scientist to perform sterility and analytical testing in our sterility testing lab. This position will report to the Quality Organization of PharMEDium.
The Lead Scientist at this facility will perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. They will abide by all documentation procedures and maintain a level of professionalism throughout each working day. The scientist must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures. All applicants for this position must embody and demonstrate the PharMEDium Core Values: Patient Safety, Flawless Quality, Operational Excellence, Employee Well Being, Service Excellence, and Respectful and Collaborative Environment. PRIMARY DUTIES AND RESPONSIBILITIES:
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- Schedule samples for analysis
- Maintaining Specialized projects through efficient project management
- Organize the receiving, storing and logging in of samples from the clean room or inventory
- Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits
- Create, review and approve data generated by other Scientist and Sterility Technicians
- Maintenance of Laboratory Notebooks
- Review and update standard operating procedures
- Coordinate Instrument maintenance
- Coordinate Method Transfers and Method Development
- Write and execute protocols and reports
- Lead OOS/Investigative reports
- Develop Quality Reports
- Train Scientist and Sterility Technicians
- Mentor and Supervise Scientist and Sterility Technicians
- Actively participle in new initiatives involving Lab topics
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- B.S. in Applicable Science field with a minimum of 5 years of pharmaceutical analytical laboratory experience and 1 years of supervisory experience of own projects or staff members.
- Aseptic Technique experience is required
- Experience in FDA regulated industry.
- Strong knowledge of and troubleshooting of all Sterility Instrumentation
- Effective organization and planning skills
- Efficient in troubleshooting laboratory equipment
- Excellent technical and verbal skills
- Must have the ability to multi-task
- Have problem solving skills
- Computer knowledge of data collection systems and/or spreadsheet software, Microsoft Word, Excel, and PowerPoint
- Understanding and experience utilizing the USP Compendia methods
- Knowledge of Sterility Analysis, GLP documentation of experiments, and Quantitative Analysis.
- Ability to travel up to 10%