HudsonAlpha Institute for Biotechnology
  • 11-Jul-2017 to 09-Sep-2017 (CST)
  • Huntsville, AL, USA
  • Full Time
  • Novocol Healthcare USA


Novocol Healthcare is Part of Septodont Canada. Septodont Canada develop, manufacture and market Dental Healthcare products.

JOB TITLE: Analytical Scientist II, Analytical R&D

DEPARTMENT: Method Development & Validation    

REPORTS TO: Senior Manager, Analytical R&D


Analytical scientist II 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, FTIR, UV 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 included but not limited to:

  1. Develop and validate HPLC and GC analytical methods for drug substances, drug product, preservatives and degradation/impurities.
  2. Perform validation experiments as per approved method validation protocols, Novocol Healthcare SOP and ICH guidelines.
  3. Perform in-process, finished product/release and stability testing of dosage forms as per the approved methods.
  4. Perform OOS and OOT investigation of drug substance and drug product as necessary.
  5. Perform analytical method transfer from R&D to QC laboratory for newly validated methods
  6. Write/revise analytical methods, method validation protocols, method validation reports, method transfer protocols/reports
  7. Perform calibration of analytical equipment as per approved procedures
  8. Document all activities in the appropriate laboratory notebook as per Novocol Healthcare procedures and cGMPs.


(approximate breakdown by percentage)

Method Development: 20%

Method Validation: 40%

Stability testing of drug product: 10%

Writing Technical Documents: 10%

Testing new raw materials: 10%

Method transfer activities: 10%




  1. Hands-on instrumentation experience using analytical techniques such as HPLC, GC, UV, FTIR etc.
  2. In depth Knowledge of separation and spectroscopic sciences.
  3. Ability to adopt fast pace working environment.
  4. Good verbal and written communication skills.
  5. Good documentation skills are preferred.


B.S/M.S in Analytical Chemistry or related discipline with 2-6 years of experience in pharmaceutical generic environment



HudsonAlpha Institute for Biotechnology
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