Analytical Scientist/QC Specialist

Analytical Scientist/QC Specialist

Full-Time

Cello Therapeutics, Inc. is a rapidly growing biotech company located in the Sorrento Valley—one of the major biotech hubs in the nation. Cello focuses on the development of novel nanotherapeutics based on biomimetic cell and platelet membrane-coated nanoparticles for cancer treatment. Our pipeline includes a few products at the preclinical stage with one product soon to enter the clinical trials. Cello offers a highly motivational, diverse, and rewarding working environment with attractive salary and benefits.

Position Summary

The new hire will:

• • Work on analytical method development and qualification/validation & testing to support preclinical development and clinical development programs.
  • Develop analytical methods and assays for cell membranes, nanoparticles, cell membrane-coated nanoparticles, drug-loaded cell membrane-coated nanoparticles, and small molecules, carry out phase-appropriate qualification/validations for these methods, perform characterization testing, and troubleshooting experiments, and author corresponding documents.
  • Establish cGMP compliant QC lab which includes evaluating and purchasing analytical instruments, setting up processes for analytical testing and release of raw materials, in-process materials and final drug substance and drug products.
  • Evaluate the manufacturing process and manufacturing process technology transfer.
  • Evaluate suppliers for raw materials, contract testing laboratories, and contract manufacturing organizations.
  • Develop analytical methods and assays in biological fluids and prepare documentation for method transfer.
  • 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.

Position Requirements

• Strong scientific background in a range of assays along with an excellent understanding and technical proficiency in analytical technologies and experience in the assessment of technical data.
• Self-motivated creative problem solver that can deal with ambiguity and declare a path forward to achieve results.
• Master’s or PhD in analytical chemistry, bioanalytical chemistry, biochemistry, molecular biology, cell biology, or an equivalent major.

Experience

• 2+ years of experience in biotech or pharmaceutical companies.
• Prior experience with analytical method development and qualification/validation for preclinical and clinical development projects.
• Hands-on experience on any type of HPLC method development.
• Hands-on experience on multiple analytical instruments for chemical and biological compounds, such as Flow cytometry, IR, HPLC, UV-Vis, plate-based assays, etc.
• Hands-on experience on aseptic techniques and cell culture.
• Hands-on experience on USP tests and understanding of USP monographs is a plus.
• Good understanding of the overall pharmaceutical/biologic product development process.
• Knowledge and understanding of cGMP regulations and ICH guidelines.
• Background knowledge and technical skills in nanotechnology and nanoparticle testing is a plus.
• Excellent verbal and written communication skills.
• Experience in writing reports and analytical methods.
• Team player with the ability to positively communicate with team members.
• 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, GraphPad Prism, JMP etc.)

Successful candidate must be authorized to work in the United States.

Cello Therapeutics, Inc. is an equal opportunity employer.