The Scientist II, QC Spray/Particulate Laboratory will perform basic tests and analysis and conduct laboratory procedures in compliance with established protocols with minimal supervision. This role will keep appropriate records, write reports and provide information to others. The role will maintain a level of appropriate scientific knowledge in assigned area and perform scientific literature searches and evaluations as required, while understanding and complying with accepted laboratory and safety procedures. This role will apply a basic knowledge of principles/theories and concepts to develop solutions to technical problems of limited scope. This role will carry out work including the recording, evaluating, analyzing and interpreting data. The incumbent may train new or less experienced employees. This role will ensure notebooks and reports are in compliance with regulatory guidelines and complete projects’ data review with time limits by verifying mathematical calculations, interpreting results and recording observations.
- This role will work with vendors and/or clients (e.g., to obtain documents required for testing or instrument maintenance3).
- Test chemical components or products as assigned. This role involves the use and maintenance of major laboratory instruments and equipment (e.g., HPLC, UPLC, FTIR, HIAC, PLM, Nasal spray test equipment, as well as wet chemical skills)
- This role will use quality systems (e.g., Documentum, LIMs, LN)
- Tests chemical components or products using major laboratory instruments such as HPLC, GC, FTIR, UV-VIS spectrophotometer, pH meter, viscometer, etc.
- Understand and execute protocols and provide information to draft in-house test standards and methods.
- This role may assist with evaluating vendor, compendial and third-party test methods for ability to perform in-house.
- This role may be asked to transcribe methods into in-house format and introduce them into our systems.
- This role may be asked to draft protocols, SOPs or methods.
- This role may assist in developing test methods and in product/formulation troubleshooting issues.
- Assist with investigations and particle identification.
- Within area responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs, as well as applicable federal, state and local regulations.
- Accurately review data using validated test methods and SOPs in a cGMP environment.
Bachelor of Science Degree in Chemistry, Biology or related science required.
2+ years’ experience in cGMP laboratory.
Flexibility in working hours may be requested – dependent on company need.
Work as a team player.
Must be eligible to work in the USA