Bench Scientist – III

Job Description

Job Summary:

• This role provides a combination of analytical laboratory testing and non-laboratory support to the QC Product Technical Support department in support of product lifecycle management.
• The Product includes analysis of biological products as well as authoring documentation to support lifecycle activities.
• Responsibilities include analytical method optimization, method validation, comparability assessments, and the evaluation of new technologies.
• The role requires a solid understanding of scientific principles underlying test methods, method validation requirements, data analysis, and cGMP requirements.

Duties and Responsibilities:

• Provide technical support for new or established analytical methods, troubleshooting methods and method improvements.
• Analyze and interpret results with a solid scientific understanding, ensuring accuracy, completeness, and compliance.
• Author test methods, validation protocols and reports, as well as supporting technical documentation for product lifecycle management.
• Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations.
• Maintain all related data and records in compliance with cGMPs and quality procedures.
• Track timelines and deliverables, and communicate effectively across teams to ensure alignment and timely execution.

Basic Qualifications:

• B.S. in Chemistry, Biology or related scientific discipline with a minimum of 5 years of applicable laboratory experience or M.S with a minimum of 3 years of relevant experience.

Preferred Qualifications:

• Knowledge and practical application of relevant analytical techniques.
• Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.
• Experience in method troubleshooting and laboratory investigations.
• Experience in validation of analytical methods.
• Experience with cGMPs and regulatory guidance.
• Experience with HPLC, CE, gel, spectroscopy.