Process Development Scientist
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Process Development Scientist to work for a leading San Diego biotechnology company.
Process Development Scientist
This position is responsible for directing product candidates through process development and support process transfer to cell therapy CMO. This position will be involved with developing the platform cell therapy production processes and ensuring processes mature appropriately to meet requirements for the stage of product development. Some travel, up to 20%.
- Developing phase-appropriate cell therapy production processes using QBD principles and aid in the transferring of process to CMO
- Develop platform production processes and ensure processes are suitable for late-stage clinical development and commercial production
- Process improvement initiatives to streamline manufacturing, or improve process robustness or cost of goods
- Lead in the startup of the cell therapy process development laboratory
- Assist in development of product-specific analytical methods to characterize and/or for release of cell therapy products
- Contribute to regulatory filings as requested by the head of Cell Therapy Development or Regulatory
- Provide creative solutions to circumvent CMC issues to achieve company goals and objective.
- PhD in immunology or related discipline with 3+ years post-graduate work experience. Candidates with Bachelor of Science or Master’s degree in immunology, chemical engineering, or other related discipline with 6+ years relevant industry experience will be considered.
- Experience developing CAR-T or hematopoetic stem cell production processes.
- Experience with GMP manufacturing of cell therapy or biological products is a plus.
- Experience with analytical methods, such as qPCR, FACS, ELISA, gel electrophresis.
- Excellent leadership and communication skills in cross-functional environments
- Problem solving capabilities with focus on creativity in problem identification and resolution and a relentless, hands-on drive to implement and accomplish company goals and objectives in a rapid-paced, changing business environment.
- Results oriented, resourceful individual with a highly entrepreneurial style and ability to achieve results in a fast-paced rapidly changing environment without the infrastructure found in large companies
- Strong presence, focus and drive to succeed—confidence, passion, and high energy.
- Ability to work in a fast-moving dynamic small company environment.
- Ability to travel up to 20%
- Outstanding written and oral communication skills are essential
- Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management
- High sense of integrity and professionalism and the ability to work well in a cross functional team environment