Sr. Associate, Analytical Development

Technical Development

San Diego

Summary Description
Summary of Position:
The Analytical Development Senior Associate will primarily focus on development and performing physicochemical assays such as of HPLC, DLS, and MicroBCA for analysis of materials and processes required for the formulation, release, and stability of API and finished drug product following GLP and GMP guidelines. In addition, this position may develop and/or perform Gel electrophoresis, Immuno-assays disintegration, and other method as needed.

Specific Responsibilities:
• Participate in development, qualification and validation Physicochemical assays such as of RP, SEC, HILIC, AEX HPLC, DLS, MicroBCA, pH and Appearance
• Routine analysis of in-process samples
• Perform release and stability testing of BDS and finished products
• Manages test samples, reagents and reference standards used in the laboratory
• Perform routine maintenance, calibration and qualification of laboratory equipment and instrumentation
• Write, revise, and maintain all assay SOPs and worksheets, instrument SOPs, and other documentation as needed
• Assist in maintaining inventories of chemicals, reagents, and reference materials
• Close attention to detail and the ability to multitask
• Analysis and interpretation of test results, identify deviations and make appropriate recommendations
• Other duties and special projects as needed may be assigned

• Knowledge of and hands on experience with chromatographic methods and Spectroscopic methods
• Possess a strong work ethic along with a solid organizational, time management, problem-solving, and interpersonal skills
• Demonstrated experience analyzing critical data and proactively solving problems
• Excellent written and verbal communication skills
• BS in Biochemistry, Chemistry or similar discipline with 5+ years’ experience, MS with 2+ years’ experience,

Preferred Qualifications:
• Good understanding of regulatory requirements, including FDA/EMA, GMP, ICH, USP/EP
• Experience working independently and thriving in a fast-paced environment
• Basic computer skills, including MS Word, Excel and Waters Empower
• Cross trained in QC disciplines
• Experience working with adenovirus
• Method development experience