Sr. Research Associate, Analytical Development

Responsibilities

• Assist in the development and optimization of analytical methods using Chromatography (SEC-HPLC, RP-HPLC), moisture/water content determination (including Karl Fisher) and/or electrophoresis (cIEF, CE-SDS) techniques for the release and characterization of biologics and drug product/medical devices.
• Execute laboratory experiments, including sample testing and characterization of biologics using chromatography, UV spectroscopy, electrophoresis, and/or immunoassay and cell-based assays.
• Analyze data, interpret results, and contribute to the preparation of reports in various formats, including Laboratory Notebooks (LN), formal reports, and presentations.
• Create and review Standard Operating Procedures (SOPs) for test method procedures and laboratory equipment operation and execute method qualification and validation studies.
• Ensure proper qualification, calibration, and maintenance of laboratory equipment in accordance with established schedules.
• Adhere to cGMP requirements as necessary and uphold compliance with standard operating procedures to maintain quality standards.
• Collaborate effectively within a team environment, demonstrate attention to detail, and communicate effectively verbally and in writing.
• Use standard laboratory, data analysis, and GMP quality systems, including Excel, GraphPad Prism, Laboratory Notebooks (LN), instrument software, and electronic quality systems, to support analytical development, testing, data review, investigations, trending, and compliant documentation.
• Adhere to laboratory and workplace safety protocols, proper use of personal protective equipment (PPE), hazard identification and reporting, and comply with the company's safety policies.
• Undertake any additional duties and responsibilities as needed to support the objectives of the laboratory.

Qualifications

• Bachelor's or Master's degree in Biochemistry, Pharmaceutical Analysis, Biotechnology, or Analytical Chemistry.
• Bachelor's degree with at least 5 years or Master's degree with at least 3 years of industry laboratory experience.
• Hands-on experience with Chromatography (SEC-HPLC, RP-HPLC) and/or electrophoresis (cIEF, CE-SDS) techniques.
• Strong multitasking abilities, effective time management skills, and excellent organizational capabilities.
• Ability to work collaboratively in a team environment, with meticulous attention to detail.