JOB SUMMARY:

Client is seeking a Sr. Associate Scientist (temp-to-hire) to contribute to our growing Analytical Development team.

• The Sr. Associate 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.
• 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.

Skills:    

QUALIFICATION REQUIREMENTS:

• Experience performing basic analytical assay techniques such as absorbance assays (UV/VIS and Bradford), liquid chromatography (HPLC/UPLC), CE-SDS, ELISA, and western blot.
• GxP knowledge. 

STRONG PREFERENCE WILL BE GIVEN TO:

• Strong experience in Liquid Chromatography and Immunoassays is highly desired.
• Experience in drafting protocols, methods, and/or procedures.

(New M.S. graduates are encouraged to apply for associate scientist position)

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