Scientific Review for project reports in area of expertise. Serving as a team leader and/or Principal Investigator (PI) and leading the technical, scientific, budgetary, and regulatory aspects of development and validation of cellular and humoral immunogenicity assays including Gx P studies.
May have up to five direct reports and working as a group leader and/or Senior Manager. Demonstrating broad knowledge in the related technical area and functioning as a subject matter expert and technical leader both within and outside of the department. Write SOPs, validation protocols, and reports Overseeing project timelines and putting best efforts into increasing productivity. Representing the
company in scientific conferences or participating in sales meetings as required. Working with management and QAU to maintain and improve quality systems. Authoring and reviewing Protocols, Reports, Deviations, and Audit responses.
Providing leadership, mentoring, and training to assigned scientific staff. Performing a QC function to review data and reports to ensure the accuracy of all laboratory-related processes. Maintaining regular communication with QAU, scientists, PIs, and other project staff and becoming the client's technical point of contact for an assigned project or program. Additional duties and responsibilities as required. Job Qualifications and Requirements: BS with at
least 8 years of relevant experience, MS with at least 5 years of relevant experience, or Ph D with at least 2 years of relevant experience.
Experience with immunoassays and cell based assay techniques like ELISA, Flow Cytometry, ELISpot, MSD, WB is critical. Experience with validating cellular and humoral immunogenicity assays under Gx P regulations including basic statistical analysis is required. Ability to quickly acquire new skills and craft creative solutions. Must be detail oriented with the ability to multi-task and work as part of a team to complete projects. Strong oral and written communication skills and the ability to work without supervision in a team environment.
Will participate in client meetings. Excellent computer skills are required. Must be proficient in Microsoft Office including Word, Excel (formulas, graphs and charts), and Power Point.
