Head of Cell-based Immunogenicity Assays (m/f/d)
- Principal Scientist Requirements: Ph.D. or equivalent in Immunology, Cell Biology, Biochemistry, or a related field with 5 or more years of experience in immunogenicity assays, including cell-based and/or competitive ligand binding assay-based neutralizing ADA assays in the pharmaceutical industry
- Sr. Principal Scientist Requirements: Ph.D. or equivalent in Immunology, Cell Biology, Biochemistry, or a related field with 7 or more years of experience in immunogenicity assays, including cell-based and/or competitive ligand binding assay-based neutralizing ADA assays in the pharmaceutical industry, and at least 2 years in a group leadership role.
- Strong knowledge of industry practices and regulatory guidance for the development, qualification/ validation of immunogenicity assays, including cell-based and competitive ligand binding neutralizing ADA assays.
- Extensive hands-on experience with the design, development, optimization, qualification and validation of immunogenicity/neutralizing ADA assays across multiple platforms and technologies (e.g, ELISA, MSD, flow cytometry and cell based-proliferation, phosphorylation, reporter and cytotoxicity assays).
- Proficiency in common software and data analysis packages (e.g., SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools).
- Experience working in a regulated environment and knowledge of GxP are required
- Responsible for the immunogenicity characterization assays and contribute to developing strategies that are necessary to further characterize the immune response in support of the global biologics portfolio from early clinical trials through post-marketing commitments.
- Proactively plan priorities among all projects in the portfolio; supervise and mentor laboratory scientists in designing, developing, optimizing, qualifying and working with CROs for validating novel cell-based neutralizing anti-drug antibody assays.
- Contribute to the development of immunogenicity assay strategies and risk assessments in support of biologics drug development programs that include novel modalities for which regulatory paths have not yet been fully established.
- Lead internal discussions regarding neutralizing ADA assay strategies for all protein therapeutics and peptides projects; apply understanding and knowledge of mechanism of action of protein therapeutics and peptides for cell-based neutralizing anti-drug antibody assay development and validation.
- Provide expert NAb assay interpretation of immunogenicity data and clearly communicate findings to multiple audiences, including health authorities
- Supervise the transfer and validation of developed neutralizing ADA assays to CROs and subsequent sample analysis and ensure high quality and timely delivery.
- Review and approve data and ensure quality and integrity, prepare clear technical reports, contribute to regulatory document preparation and participate in regulatory interactions, and deliver updates to department management.
- Maintain current knowledge of the immunogenicity and neutralizing ADA assay field and propose and implement strategies that are in line with industry practices and regulatory requirements.
- Take initiative to increase assay development throughput by optimizing strategies and processes through implementing new technologies, equipment, and automation.
- Hire and retain talent, develop junior scientists in scientific and professional growth.
- Comply with all applicable regulations; ensure that work performed in area of responsibility is conducted in a safe and compliant manner; maintain proper records in accordance with GLP, GCP, SOPs and policies.
Boehringer Ingelheim Pharma GmbH & Co. KG
CT, Richfield [USA]