Associate Scientist

Catalent•Winchester, KY

5d•Onsite

About The Position

The Associate Scientist is responsible for performing analytical research and development work in the Analytical R&D Department. The Associate Scientist work/assist on method development, method transfer, method verification and method validation under appropriate guidance along with routine release and stability testing in support of clinical development and registration activities required for the regulatory submissions.

Requirements

Bachelors Degree in Chemistry, Pharmaceutical Sciences or Life Sciences Required (Preferred in Analytical Chemistry)
Must have at least one year of experience in pharmaceutical industry and 1+ years of experience in analytical testing/research experience using HPLC/GC/UV, etc.
Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, µg/mL, etc.), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc.
Basic understanding and knowledge of analytical chemistry and chromatographic techniques (e.g., LC/GC/dissolutions) and spectroscopic (e.g., UV) analysis.
Demonstrate Knowledge and ability to understand and follow ICH guidelines (ICH Q1, Q2, Q3 etc.) including other regulatory guidelines.
Adhere and perform all lab job duties/responsibilities according to applicable SOP's related to DEA scheduled drugs, safety, waste management and housekeeping and work with the team in improvement of the processes and procedures.

Responsibilities

Analysis of finished products, in-process materials, raw materials, according to the assigned specifications, methods, and protocols according to cGLP and cGMP.
Document, process, report the data as applicable to support the team in timely fashion.
Perform analysis as required to support assigned testing using KF titrations/Dissolutions/IR/UV spectrophotometers, LC to perform dissolutions/assays/BU/CU, impurities and data processing using Empower and document per applicable test methods/specification/protocols etc.
Use Empower software- creating instrument/processing/report methods and performing online empower calculations for assay/dissolutions/impurities etc.
Knowledge of Trackwise for managing deviations and investigations and ability to manage /handle with guidance from supervisors/senior team members.
Troubleshoot and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members.
Perform/assist team members in method transfers, Compendial verifications or full method validations (forced degradation and calculating mass balance/peak purity to prove stability indicating nature of the method) per applicable guidances (USP <1224>, <1225>, <1226> ICH Q2 etc.)/SOPs with guidance from the supervisors/senior team members.
Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols and report/document per applicable specification/stability protocols.
Escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members.
Other duties as assigned.
Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.
Maintaining clean environment for laboratory operations.
Use of and safe handling of glass canisters, chemicals, and other required equipment.