Analytical Services Chemist II
Job Summary:
This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in-process, release and stability samples for per-commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications and method transfers. Work on a team of 3 or more analysts. No direct reports, no purchase approval or budget responsibilities.
Responsibilities:
- Perform accurate and timely analysis of assigned samples according to current analytical procedures, SOPs, laboratory guidelines and safety requirements
- Testing performed to include basic and complex lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, Assay/Impurities by HPLC, Dissolution, Residual Solvents by GC, and wet chemistry techniques such as titrations and sample derivatizations
- Document all laboratory testing and maintain accurate and legible notebooks and records
- Peer review of data, reports and notebooks
- Execute method transfer/validation protocols
- Perform laboratory troubleshooting and propose solutions
- Mentor/Train team members on new/revised skills and testing procedures
Education/Qualifications:
- BS Degree in Chemistry or related field and a minimum of 3 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
- AS Degree in Chemistry or related field and a minimum of 5 years of pharmaceutical experience in a cGMP-regulated environment
- BS Degree in non-science field and a minimum of 7 years of pharmaceutical experience in a cGMP-regulated environment
- Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
- Excellent in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
- Excellent oral and written communication skills
- Strong organization, time management, leadership and troubleshooting skills
- Demonstrated ability to work as part of a cross-functional team
- Expertise in Microsoft Word and Excel
- Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)
- Travel < 5%
Work mainly performed in lab
