Job Description

Role Overview

Within Small Molecule Chemistry and Manufacturing Control (CMC) Development, Analytical Research & Development focuses on utilizing measurement scientists of analytical chemistry to inform the development of new chemical entities and the associated formulations dosed in a preclinical and clinical setting across a wide range of pipeline programs.  The group is highly cross-functional and works closely with internal Analytical R&D colleagues as well as colleagues within Discovery, Process Chemistry, Pharmaceutics and Drug Product Development.

Key Responsibilities

Responsible for performing method development and execution of methods (e.g. (U)HPLC with UV/Vis or MS detection, Karl Fischer titration, GC with FID or MS detection, dissolution, physical measurements, etc.) for the characterization and development of small molecule active pharmaceutical ingredients, intermediates, starting materials, pre-clinical formulations, and accelerated stability samples.

Independent and productive in performing lab work with team lead guidance, including, but not limited to, solution and sample preparations, stability studies, instrument maintenance, and buffer preparations, after appropriate training.

Troubleshoot basic technical issues with team lead guidance.

Responsible for efficiently processing and visualizing analytical data and summarizing basic trends within the data.

Responsible for maintaining and keeping an accurate laboratory notebook with high attention to detail.

Validate analytical methods and perform testing on clinical supplies, following current Good Manufacturing Practices (cGMPs).

Member of functional and cross-functional teams driving business initiatives, executing activities with team lead supervision and guidance.