The Agenus Quality Control (QC) Bioassay Sr. Specialist will be the subject matter expert for the Bioassay function. This position will handle the internal validation/qualification and tech-transfer of cell-based functional assays.
Roles and responsibilities:
• Ensure QC operations comply with cGMP throughout the lifecycle of biological product development
• Perform development/tech-transfer, validation, implementation, and continuous improvement of novel cell functional assays and other peptide-based products.
• Independently lead investigations in collaboration with Agenus QA to address change control, deviations, Out-of-Specification (OOS) and oversee the implementation of effective corrective/preventive actions
• Authors risk assessment, standard operating procedures (SOP), method transfer and validation protocols and reports as required to support QC Bioassay and general operations
• Support Agenus Regulatory submissions (e.g., IND/BLA), authoring/reviewing/approving CMC sections and participating/assisting regulatory inspections and information requests.
• Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to Analytical methods, and cell based potency assays.
• Establish, develop, and/or optimize analytical methodology to test the potency of protein products (in-process and final) using binding or cell-based assays
• Designs and independently conducts scientific development projects from inception to completion
• Provides training on areas of technical expertise and compliance issues relevant to the lab setting
• Conducts and directs assays and lab procedures according to and in compliance with cGMP
• Prepares protocols, final reports, investigations, and deviations as needed
• Conducts critical review of results and reports data appropriately
Qualifications and Education Requirements:
• A least 5+ years of relevant experience with cell-based assay or equivalent for Bachelors’, 3+ years for Master’s in the Quality Control or related field or equivalent experience.
• Experience in qualification and/or validation of cell-based and immunological bioassays for GMP lot release and well-versed in cGMP/ICH/FDA/EU regulations and guidelines
• Experience responding to health authority (FDA, EMA, etc.) information requests and participating in FDA audits
• Ability to work within established timelines and manage changing priorities in a fast-paced environment
• Ability to comprehend and draw conclusions from scientific and numerical data
Experience with cell-based assays and their application in biological characterization for biologics are required
• Ability to use proficiently advanced laboratory equipment, such as, but not limited to; automated cell counters, plate readers, etc.
• Experience with Flow cytometry techniques using FACSLyric or FACSDiva and data interpretation is a plus
• Experience with analytical methods development.
• Experience with large molecules with exposure to vaccines and cell therapy.
• Outstanding general and scientific writing skills.
• Candidate should be knowledgeable with cell culture, analytical, raw material, stability, aseptic processing, and microbiological test methods
• Experience with cell-based assays and their application in biological characterization for biologics required
• Experience working and collaborating with cross-functional biologics development teams
• Good interpersonal skills and ability to work with people with varying backgrounds and skill sets
• Excellent written and verbal communication skills coupled with the ability to prioritize multiple tasks and have the confidence to challenge existing systems & processes
• Innovative, critical-thinking QC Specialist knowledgeable in the application of ICH Q8/Quality by Design (QbD) principles to the development and continuous improvement of bioassays throughout the product lifecycle
• Capable of working independently in a high-paced team environment, prioritize work for multiple projects and meet deadlines
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