Drug Product and Stability Chemist I - 1st Shift
DRUG PRODUCT & STABILITY CHEMIST I
This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products. Work on a team of 6 or more analysts. No direct reports. No purchase approval or budget responsibilities.
- Perform accurate and timely analysis of in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements
- Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution
- Document all laboratory testing and maintain accurate and legible notebooks and records
- Peer review of data, reports and notebooks
- BS Degree in Chemistry or related field
- AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment accepted in lieu of 4-year science degree
- BS Degree in non-science field and a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
- Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
- Experience in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
- Excellent oral and written communication skills
- Strong organization and time management skills
- Demonstrated ability to work as part of a cross-functional team
- Working knowledge of Microsoft Word and Excel
- Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)
- Work mainly performed in lab
- Travel < 5%
- Decisions require some judgment. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.
- Individual contributor, not responsible for the work of others.
- Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters. Occasionally contacts individuals outside the department or functional area.