This individual is responsible for independently performing routine tasks in the QC laboratory under direct supervision.Essential Duties:
- Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing.
- Maintain the laboratory in accordance with SOPs.
- Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.
- Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.
Knowledge, skills and abilities:
- Familiar with basic analytical techniques and executes tasks below under supervision or under the direction of a test method, standard operating procedure, or a protocol.
- Nasal Spray testing
- Develop method validation knowledge.
- Develop instrument qualification knowledge.
- Develop understanding of cGMPs.
- Develop investigative skills for OOS, OOT and aberrant result laboratory investigations.
- Good oral and written communication skills.
- Recommend and implement as required, innovative approaches to problem solving.
- Other duties as assigned.
- Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
- Team player with well-developed interpersonal, organizational, and communication skills.
- Maintains proper social etiquette and self-control when dealing with stressful situations.
- Bachelors in Chemistry or related field with at least 3 years of pharmaceutical industry experience
- Masters degree in Chemistry or related field with at least 2 years of pharmaceutical industry experience
- PhD in Chemistry or related field
- Qualified to work with controlled substances
Company DescriptionSummit Biosciences is a specialized pharmaceutical company that develops, manufactures and commercializes prescription nasal spray products.