Principle Scientist (Bioassay Development) - Fremont, CA

Hayward, California
Apr 22, 2021
May 05, 2021
Organization Type
Principle Scientist (Bioassay Development) - Fremont, CA

Job Description:
• Responsible for leading method development, optimization, and phase-appropriate qualification of custom bioassays for clients per ICH guidelines, meeting defined project timelines and producing high quality data and reports
• Participates in intake phone calls with new clients to establish project requirements and deliverables, and teleconferences with clients to communicate progress of on-going projects
• Oversees development, troubleshooting, and qualification of new bioassays in product portfolio intended for potency / lot release or neutralizing antibody (NAb) applications.
• Implements design of experiment (DoE) approaches in bioassay development and qualification process to understand performance characteristics and improve robustness of bioassays
• Writes detailed methods to facilitate assay transfer and documents critical manufacturing information in the development of ready-to-use cell banks and transfers to Cell Manufacturing team
• Serve as liaison between the Bioassay, Cell Manufacturing, Customer support and Marketing teams to ensure successful implementation of bioassays at customer sites
• Prepares and collaborates with QA and Marketing in finalizing all appropriate documentation (SOPs, user manuals, qualification reports, etc.) to support product launch or transfer of assays / methods to client sites
• Participates in method transfer phone calls with clients, and training of technical support staff who will be responsible for training employees at client sites to transfer methods
• Prepares data and scientific content for presentations, posters, webinars, manuscripts, white papers, or other relevant company materials
• Demonstrates and promotes the company vision
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned
• Owns the accountability and responsibility of delivering to client needs and timelines
• Provides cross-functional support to other departments as required
• Adjusts work hours as needed to meet client deadlines
• Adheres to site employee health and safety (EHS) requirements

The Ideal Candidate would possess:
• Experience in GMP/GLP environment strongly preferred.
• Demonstrated knowledge of ICH guidelines for bioassay method development/qualification and validation required.
• Experience dealing directly with clients in industry setting (e.g. CRO/client relationship).
• Experience with design of experiment (DoE) in bioassay development
• Experience developing cell-based assays for neutralizing antibody detection
• Effective oral presentation skills and comfort with public speaking

Basic Minimum Requirements:
• MS/PhD or equivalent experience in cell biology, biochemistry or related discipline, with a minimum of 5 years of industrial experience in Bioassay development, or method qualification/validation.
• Prior hands-on experience using cell based assays for protein /antibody characterization and release testing
• Experience in method development, qualification, and/or validation and transfer of bioassays utilized in lot release and stability testing required
• Experience using PLA, Softmax Pro, JMP or a related software package for analyzing data from potency assays is essential
• Experience drafting qualification or validation reports, or SOPs for assay transfer to CRO/CMO partners strongly preferred

For immediate consideration apply today!

Questions? Please reach out to Dustin at


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