QC Scientist - Method Validation

JOB SUMMARY:
We are seeking 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 internal projects.

This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support.

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.
• Provide support for laboratory operations – inventory tracking, reagent preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.
QUALIFICATION REQUIREMENTS: • Extensive experience performing basic analytical assay techniques such as absorbance assays, chromatography, CE-SDS, ELISA/AlphaLISA, and western blot.
• Extensive experience developing/authoring protocols, methods, and SOPs and performing method qualification/validation activities.
• Strong written and verbal communication skills. (Native or near-native English speaker)
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• 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 or working knowledge in neurotoxin as therapeutics.
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.

Pay Rate Range: $40-62/hr depending on experience level