Research Associate, Analytical Chemistry
 Position Summary:​​

The new hire will:
  
  • Perform analytical method development for small molecules and polymers.
  • Develop analytical methods (HPLC, GC, GPC, in vitro release, etc.) for nanoparticles
  • Create stability protocols and review critical documents.
  • Assist Senior Scientist with establishing cGMP compliant QC lab, which includes evaluating the release of raw materials, in-process materials, and final drug substance and drug product.
  • Assist in analytical method development for small molecules and polymers.
  • Contribute to the qualification/validation & testing to support preclinical development and clinical development programs.
  • Assist with method transfers & stability projects to contract manufacturing organizations (CMOs).
  • Evaluate suppliers for raw materials, contract testing laboratories, and contract manufacturing organizations.
  • Regularly report work status and prepare written reports on work performed.
  • Cooperatively work with personnel in other departments, i.e. Formulation and Process Development, Quality Assurance and Regulatory Affairs, and collaborating partners.
  • Assist formulation group with characterization testing, and troubleshooting experiments.

Skills/Qualifications:
   
  • BS or higher in analytical chemistry, bioanalytical chemistry, biochemistry, molecular biology, cell biology, or an equivalent major.
  • 3-5+ years of experience in biotech or pharmaceutical companies.
  • Strong scientific background in range of assays along with an excellent understanding and technical proficiency in modern analytical technologies, method development, and validation in accordance with FDA regulations
  • Prior experience with analytical method development and qualification/validation for preclinical and clinical development projects.
  • Experience in the assessment of technical data and GLP documentation practices
  • Self-motivated creative problem solver that can deal with ambiguity and declare a path forward to achieve results.
  • Hands-on experience on any types of HPLC method development.
  • Hands-on experience on multiple analytical instruments and methods for chemical and biological compounds, such as IR, HPLC, UV-Vis, plate-based assays, pH meter, in vitro drug release testing, etc.
  • Hands-on experience on USP tests and understanding of USP monographs is a plus.
  • Knowledge and understanding of cGMP regulations and ICH guidelines.
  • Background knowledge and technical skills in controlled drug release, nanotechnology and polymeric nanoparticle testing is highly desirable.
  • Background knowledge of, or prior experience in, tissue culture is a plus.
  • Excellent verbal and written communication skills.
  • Experience in writing reports and analytical methods.
  • Highly organized and able to work independently in a fast-paced environment under limited supervision.
  • Professional, dedicated, detail-oriented, and self-motivated.
  • Proficiency with word-processing, spreadsheet, chemical drawing, and basic statistical analysis (i.e. MS Word, Excel, ChemDraw, JMP etc.)
  

Please submit a resume/CV to [email protected] if interested.