Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight chronic diseases. The company's technologies are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases. CMB305 and G100, the two leading product candidates focused in cancer immunotherapy, are the first products from its two separate discovery platforms targeting dendritic cells in vivo, ZVexÂ® and GLAASÂ®. Both ZVex and GLAAS also have potential applications in infectious disease and allergy as demonstrated by ongoing pharmaceutical collaborations. Immune Design has offices in Seattle and South San Francisco.
The Principal Scientist/Director, Analytical Development is responsible for development of new methods or improvement of existing methods for characterization and release of our drug substances and drug products and for process characterization. Works closely with Research, Process Development and Quality Control to provide the appropriate level of support. A key focus for this position is identifying and implementing process analytical tools and technologies to improve process understandings and drives innovation, efficiency and productivity in the lab
- Manages research associate performing laboratory-based studies to support assay development
- Participates as a Member of Project Teams
- Leads an assay development scientific meeting that has cross functional representation from Research, Clinical, Process Development and QC
- Provides scientific content for regulatory submission
- Interacts with CMOs and may be involved with assay transfer activities
- Writes, reviews and/or approves Technical Protocols, Method development and Qualificationreports
- Ensures timely review of all data supporting technical studies.
- Ensures laboratory equipment and instrumentation upkeep which include troubleshooting, PM/calibration/qualification as needed
- Directs and controls the activities of a functional area through supervision of research associates
- Provides leadership, motivation and career development of laboratory staff
- Ph.D in a scientific discipline such as Immunology, Virology, Biochemistry, Microbiology or Bioengineering or related discipline
- Prior experience working in a BSL2 Lab environment is a plus
- Hands on experience with ELISA, qPCR based assays, and cell based bioassays
- Knowledge of cGMP, cGCP, FDA regulations, and ICH guidelines, including their interpretation and implementation, is required.
- Able to deal with time demands, incomplete information or unexpected events; able to communicate well and work effectively in a team/matrix environment.
- Knowledge of the principles and practices of basic computer applications used in general office settings, including word processing, spreadsheet, database management, presentation software, and internet search engines.
- Positive attitude and motivation to work with the team to meet corporate and personal goals.
- Good interpersonal skills and ability to influence clinical site staff in a positive manner.
- Excellent organizational and planning skills.
- Keen ability to identify issues and take appropriate actions.
- Proven ability to build and maintain positive relationships with management, peers, and subordinates.
- Excellent written and verbal skills required.
- Strong analytical and problem solving skills.
- Attention to detail required, particularly in documentation of manufacturing and clinical activities.
- Able to travel