Posted on Apr 5, 2021 by Pfizer
The High-throughput Clinical Immunoassays & Diagnostics (HCID) group within Pfizer Vaccines R&D is seeking a biologist with experience in the development of neutralization assays for a Scientist role in the Neutralization Assay Group. The individual will be responsible primarily for the Phase 3 clinical testing for the RSV (Respiratory Syncytial Virus) neutralization assay and may support other assays within the group. The candidate will function as a senior member of the Neutralization Assay Group and manage a small team. As an integral member of this dynamic team, the incumbent must have a strong work ethic and be highly collaborative with the other group members. All work is to be done in a compliant manner according to relevant SOP guidelines and GLP and/or GCLP guidelines, when required.
Manage clinical testing for the RSV Neutralization Assay, including scheduling assays, managing the training of entry level scientists, and managing strategy for clinical testing to meet program timelines.
Perform experiments related to the development and optimization of bio-functional assays.
Provide scientific input on experimental design and data analysis.
Oversee the preparation of human and pre-clinical animal serum samples for testing.
Perform activities related to maintenance of cell lines.
Assist in the preparation and qualification of new reagents.
Assist in updating and writing documents including standard operating procedures, test methods, reagent reports, and data archiving.
Oversee the review of clinical data packages.
Oversee the maintenance of the laboratory, including ordering/restocking supplies, updating reagent inventory, and ensuring cleanliness.
Satisfactorily complete all cGMP/GLP and safety training in conformance with Departmental requirements.
Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.
BS in Biology, Immunology or equivalent degrees with 6 years of relevant experience or MS Degree with 4 years of relevant experience (Non-PHD).
Previous management experience.
Laboratory experience in bio-functional assay development.
Experience working in high-throughput testing laboratories operating under GCLP guidelines, including SOPs, instrument IOQ/PQ, and good documentation practices.
Experience handling infectious agents and biological materials including RSV.
Proficiency with Excel, PowerPoint, and statistical software including GraphPad Prism.
Should be self-motivated and able to work effectively as part of a team.
Should possess the ability to multi-task and align priorities with program objectives.
Excellent verbal and written communication skills.
The position has physical requirements of basic office and laboratory work (sitting, standing, and walking).
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