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As a member of the Bioanalytical Development Team, this scientist’s primary responsibility will be to lead the development, validation, and implementation of functional cell based assays for assessing neutralizing potential of anti-drug antibodies to therapeutic proteins, nucleotide acid based therapeutics, and other novel therapeutic modalities. Responsibilities:
- Responsibility for the development, qualification and validation of cell based neutralizing antibody assays and responsible for oversight of all cell based neutralizing assay performance both internally and at CRO partner laboratories in support of the BMS portfolio.
- Knowledge of the mechanism of action of therapeutics in BMS pipeline to aid in development of appropriate cell based functional assays.
- Leads a team of approximately three scientists in the development of bioanalytical functional (cell-based) assays.
- Understanding of immunogenicity risk assessment for biotherapeutics
- Contributes to the preparation of technical reports, Health Authority filings and queries.
- Contributes to the preparation and presentation of scientific material at internal and external meetings.
- Ensures compliance with departmental SOPs, safety guidelines, and other applicable regulations.
- Ensures that notebooks and other documents are reviewed and compliant as per departmental SOPs and health authority regulations.
- Employ the most current scientific techniques and methodologies by keeping abreast of literature, presentations and health authority guidelines.
- Achieve objectives in a manner consistent with the BMS Biopharma Behaviors.
- Incumbent will be encouraged to publish in peer reviewed journals as part of project publication plans.
- Interaction with multiple teams in pre-clinical and clinical development as subject matter expert on immunogenicity and on neutralizing antibody assays.
- PhD in relevant scientific discipline (biology, immunology, biochemistry, chemistry, cell biology etc.) with 10 years of relevant industry experience;
- Should have proven technical expertise and hands-on experience with development, execution, and troubleshooting of cell based functional cell based assays, mammalian cell culture, technologies such as ELISA (Direct and Indirect sandwich formats), Luminescence, Colorimetric, LC/MS/MS detection platforms.
- Extensive experience with development of cell based functional assays in GMP (potency assay) or GLP laboratory (NAb assay) required.
- Basic understanding of immunology, oncology, and other therapeutic areas in order to develop functional assays that reflect mechanism of action.
- Experience with developing automated sample handling and assay processes is desirable.
- Knowledge of GLPs, 21 CFR Part 58, Bioanalytical Guidance (FDA, EMA), Immunogenicity Guidance (FDA, EMA) is desirable.
- A working knowledge of protein biochemistry and characterization is beneficial.
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