CMC Development Scientist
- Carry out research and development activities for process and formulation development.
- Design and conduct processing and formulation research to develop robust and functional cell membrane based biological nanoparticle drug products utilizing Quality by Design (QbD) and risk assessment concepts.
- Facilitate process scale up and manufacturing activities to provide quality materials for nonclinical and clinical trials
- Perform analysis and identify trends in the inspection of finished products, in-process materials, and bulk raw materials and recommend corrective action when necessary.
- Facilitate formulation development and optimize scale up process to enable tech transfer to GMP facility
- Provide technical support for batch manufacture, release, and stability program.
- Facilitate development and implementation of CMC SOPs.
- Track CMC project plans and progress to ensure clarity of deliverables and timing.
- Evaluate and manage tech transfer with contract manufacturing organizations.
- Maintain accurate lab notebooks and complete development reports. Author relevant documents required to support INDs and BLAs.
- Author production batch records for the manufacturing of GMP materials.
- Supervise/train junior level engineers/scientists.
- Cooperatively working with personnel in other departments/collaborators: Analytical Development, Quality Assurance and Regulatory Affairs, and collaborating partners.
- Strong scientific background in nanoformulations and process development.
- Self-motivated creative problem solver and can deal with ambiguity and declare a path forward to achieve results.
- PhD or Master in pharmaceutics, industry pharmacy, biochemistry, chemical engineering, biomedical engineering or any equivalent major.
- 5+ years of experience in biotech or pharmaceutical companies.
- Experience with drug product analytical method development, transfer, and validation for injectable products.
- Prior experience with biological process and formulation development, process optimization, and QbD.
- Experience in nanotechnology and nanoparticle testing and formulation development.
- Knowledge and understanding of cGMP regulations and ICH guidelines.
- Excellent verbal and written communication skills. Experience in writing reports and analytical methods
- Team player with ability to positively communicate with team members
- Must be highly organized and able to work independently in a fast-paced environment
- Must be 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.)
Successful candidate must be authorized to work in the United States.
Cello Therapeutics, Inc. is an equal opportunity employer.