Method Development Scientist

Description

JOB SUMMARY:

• A Scientist to contribute to our growing Analytical Development team.
• The Scientist will participate in a team responsible for all aspects of method development, qualification, and execution for the characterization of complex biologics.
• This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for Client projects.

ESSENTIAL DUTIES and RESPONSIBILITIES:

• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Operate and maintain (as well as overseeing the installation of) sophisticated analytical instrumentation and associated computer control systems.
• Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area.
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

Skills

QUALIFICATION REQUIREMENTS:

• Extensive experience developing/authoring protocols, methods, and SOPs and performing method qualification/validation activities.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
• Strong GxP knowledge.

STRONG PREFERENCE WILL BE GIVEN TO:

• Expert level understanding in drafting protocols, methods, and/or procedures.
• Expert level understanding in method qualification and validation.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.

Education:

• Master’s degree in biological sciences or related field with 5+ years or PhD with 2+ years of progressive experience in the biotechnology or pharmaceutical industry.