Analytical Development Scientist - Cdmo

Location: San Diego, California

Company: Biologics Contract Development and Manufacturing Organization (CDMO)

Responsibilities:

• Prepare and review technical reports, method validation protocols, and other documentation to support regulatory filings and client requirements.
• Stay abreast of current industry trends, regulatory guidelines, and technological advancements in analytical techniques and contribute to the continuous improvement of analytical processes.
• Conduct analytical experiments, perform data analysis, and interpret results to generate reliable and accurate analytical data for process optimization and product development.
• Collaborate with cross-functional teams to support method development and validation activities, ensuring the timely delivery of analytical results to meet project timelines.
• Establish specifications and test methods for raw materials, in-process samples, and final drug products, ensuring compliance with regulatory guidelines and industry standards.
• Maintain and troubleshoot analytical instruments and equipment, ensuring their proper functioning and calibration to deliver accurate and precise analytical results.
• Collaborate with external partners, including contract testing laboratories and clients, to coordinate analytical activities and address technical inquiries.
• Design and develop analytical methods for the characterization and quality control testing of biologics products, including monoclonal antibodies, recombinant proteins, and other biopharmaceuticals.

Requirements:

• PhD or Master's degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. A Bachelor's degree with significant relevant experience may also be considered.
• Familiarity with regulatory guidelines (e.g., FDA, ICH, USP) related to analytical method development, validation, and GMP compliance.
• Minimum of 3 years (PhD) or 5 years (Master's) of experience in the biopharmaceutical industry, preferably in an analytical development or quality control function.
• Strong knowledge and hands-on experience in developing and validating analytical methods for the characterization of biologics, including techniques such as HPLC, CE, MS, ELISA, SDS-PAGE, and Western blot.