Scientist, Analytical Development IV

JOB SUMMARY:
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 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.
• Lead scientific initiatives and technical projects to meet department objectives.
• 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.
Skills:
QUALIFICATION REQUIREMENTS: • Extensive experience performing basic analytical assay techniques such as absorbance assays, chromatography, LC/MS, CE-SDS, ELISA, and western blot.
• Familiarity in interpreting data from common characterization techniques such as AUC, LC/MS, MFI, DLS, and CD.
• Extensive experience developing/authoring protocols, methods, and SOPs.
• Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics; R, Python, or other statistical tools preferred.
• 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.
• GxP knowledge.
STRONG PREFERENCE WILL BE GIVEN TO: • Expert level experience in Liquid Chromatography and LC/MS is highly desired.
• Experience in drafting protocols, methods, and/or procedures.
• 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 (post-doc experience may be considered).

Pay Rate Range: $60-72/hr depending on experience