DEPARTMENT/TEAM DESCRIPTION

Biological Development Assay Development, Quality Control (BD AD-QC)

POSITION SUMMARY

The purpose of this position is to support analytical testing for a wide variety of methods to reach department timelines

POSITION DUTIES & RESPONSIBILITIES

• The candidate will perform routine Clinical and Development testing activities with expertise in a wide variety of methods ranging from Chemistry to Biochemistry involving, but not limited to, HPLC, ELISA, qPCR, A280, Western Blot, PAGE, Protein Concentration, Osmolality, etc. Additionally, candidate will review data generated by other analysts on these, as well as other methods, with appropriate training.
• Must be able to follow Standard Operating Procedures (SOPs) in performance of laboratory testing to complete assigned tasks to meet release timelines and ensure quality. Must be able to document test results accurately and legibly to meet regulatory requirements and ensure completeness and accuracy per cGMPs and/or cGLPs.
• Must be able to compile and enter data into LIMS, Excel, or other application as needed, to be used for tracking and trending purposes.
• Experience using Empower, SoftMaxPro, PLA, and OpenLAB a plus.

REQUIREMENTS/PREFERENCES

Education Requirement(s):

• BS/BA

Requirements:

• Ideal candidate will have 2 years of experience in a cGMP laboratory environment with demonstrated ability to learn new skills to achieve proficiency.

Preferences:

• Empower chromatographic software
• isoelectric focusing
• Capillary Electrophoresis
• ELISA
• Plate-based/cell-based Potency
• Micro-flow imaging

BAY1JP00019123