Scientist, Bioassays - CMC Analytical Development
San Francisco, CA
We are very excited to present a direct hire position for a Scientist role at a clinical stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.
We are seeking an experienced Analytical Development scientist to conduct assay development, technology transfer, qualification/validation, and to provide scientific oversight of the methods at satellite labs and contract testing organizations. The individual will develop cell-based and other biological and functional assays to support biologic therapeutics programs such as antibody therapies, viral vectors, and cell therapies. This role will involve laboratory work, including the design and interpretation of laboratory experiments, as well as providing representation on cross-functional teams, and may include mentor-ship of lab personnel. The Analytical Development Scientist will also provide subject matter expertise for technical visits and agency inspections. Responsibilities will also include authoring reports, white papers, and relevant sections of regulatory filings.
- Assay development, troubleshooting, transfer, and implementation of cell-based and other functional methods for both process characterization and release testing.
- Participate in the design and startup of development and QC laboratories
- Support method life-cycle activities for analytical methods including assay transfer, design of validation studies, designing assay maintenance programs, and developing assay controls and trending programs
- Provide subject matter expertise for assay work conducted at contract organizations and satellite labs, technical reviews and agency inspections
- Author reports and relevant sections of regulatory filings
- Work cross-functionally to support other areas of the CMC Analytical organization, such as management of contract organizations, stability, raw materials programs, and assay life-cycle management.
Qualifications and Experience:
- Background in biological therapeutics such as antibodies and vaccines is required
- Assay development experience in biological assays such as potency methods (including bioassays), ELISA, cellular cytotoxicity, ADCC, ADCP, surface plasmon resonance (SPR)
- Experience in developing and transferring methods for use in Quality Control or other regulated environments, with an understanding.
- Experience in analytical method life-cycle (assay transfer, qualification, validation, and maintenance) is preferred
- Understanding of FDA, ICH, and EP or other regulatory agency guidance associated with analytical methods and assay qualification
- Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents
- Excellent proficiency in working on cross-functional, collaborative teams
- Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects
- BS/MS and 10+ years or PhD and 4+ years of experience in the biotechnology industry is required
For immediate consideration, please email Email blocked - click to apply
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