A leading pharmaceutical dentistry company is seeking a Senior Analytical Scientist for its new-but-growing team in Huntsville, AL, working at a state-of-the-art facility.
Sr. Analytical Scientist in R&D is responsible for the development and validation of analytical methods for new drug products and new drug substances. These methods include assay, impurities/degradants, preservatives, alcohol and any other analytes to be monitored in the finished product. The analytical scientist will be using UPLC, HPLC, GC, UV, FTIR and other analytical instruments as needed. Write protocols and final reports in accordance with current FDA regulations, ICH guidelines, USP monographs, and Novocol Healthcare SOPs.
Responsibilities are included but not limited to:
- Develop analytical methods for drug substances, drug product, preservatives and degradation/impurities in the new drug products.
- Perform validation experiments as per approved method validation protocols, Novocol Healthcare SOP and ICH guidelines.
- Support formulation scientist to develop stable and robust drug product by generating analytical data of prototype formulation.
- Support formulation scientist by reverse engineering of RLD drug products.
- Perform lab investigation of OOS and OOT results of drug substance, raw materials and drug products.
- Perform in-process, finished product/release and stability testing of dosage forms as per the approved methods
- Perform analytical method transfer from R&D to QC laboratory for newly validated methods
- Write/revise analytical methods, method validation protocols, method validation reports, method transfer protocols/reports
- Perform calibration of analytical equipment as per approved procedures
- Document all activities in the appropriate laboratory notebook as per Novocol Healthcare procedures and cGMPs.
WORK PERFORMED: (approximate breakdown by percentage):
- Method Development: 30%
- Method Validation: 40%
- Writing Technical Documents: 10%
- Testing new raw materials: 10%
- Method transfer activities: 10%
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
- Hands-on instrumentation experience using analytical techniques such as UPLC, HPLC, GC, UV, FTIR, Mastersizer etc. Knowledge of separation and spectroscopic sciences.
- Good verbal and written communication skills.
- Good documentation skills are preferred.
- Ability to adopt fast pace working environment.
EDUCATION AND/OR EXPERIENCE:
- B.S/M.S/Ph.D. in Analytical Chemistry or related discipline with 4-6 years of experience in pharmaceutical generic environment