Senior Scientist

Job Description

Job description

In this exciting opportunity, you will be designing and executing various laboratory experiments to support development, validation and transfer of analytical methods for monitoring process related impurities in Biologics.

You will be also authoring, reviewing and/or approving technical documents or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical impurity methods (protocols, reports, test methods, etc).

This role will have you assisting in evaluation and the following implementation of new technologies.

Candidates should have familiarity with several of the below laboratory techniques; they should also possess expertise with the following:

Development, validation and transfer of analytical impurity methods to support biological product release

Mentoring and Training junior scientists on relevant laboratory techniques and instrumentation relating to measurement of process related impurity assays

Support in the lab or oversee characterization of critical reagents (Antibodies, conjugated antibodies, assay controls, calibration standards) using a variety of fundamental biochemical methods including:ELISA

1 and 2D Gel Electrophoresis

Western Blot

HPLC/LCMS

Supporting troubleshooting and assay remediation activities based on significant technical expertise in plate-based impurity methods and fundamental understanding of analytical development principles.

Responsible for documentation of development and validation data, generation of high-quality written study protocols, reports, and leading cross functional meetings

Responsible for maintaining awareness of current regulatory guidelines that may apply to methods being validated (ICH quality guidelines etc).

Responsible for documentation of development and validation data, generation of high-quality written study protocols, reports, and leading cross functional meetings