Quality Control Assay Development Scientist

Vector BioMed is a state-of-the-art contract development and manufacturing organization (CDMO) specializing in best-in-class lentiviral vectors. We are looking for a highly motivated and experienced Scientist to join our growing team. Responsibilities include developing, qualifying, and validating analytical methods commonly used for in-process, stability, and release testing of GMP manufactured viral vectors in a QC setting. The ideal candidate will have a strong background in assay development and qualification of methods used to characterize GMP manufactured biologics.Responsible for assay development, qualification, validation, and generation of reports. Methods may include cell-based assays, molecular assays (PCR), immunoassays, flow cytometry, etc.Responsible for method transfer from internal and external clients.Work collaboratively within a team to achieve QC objectives for timely testing of manufactured products and contribute to, or lead, troubleshooting activities.Draft, review, and follow written procedures and adhere to good documentation practices.Participate as a team member on cross-functional teams and be given project assignments to train, develop problem-solving skills, and increase technical expertise.Proactively identify and implement changes to business and QC processes that improve efficiency and robustness.Adhere to quality standards for job training and ensure GMP compliance.Qualifications:Advanced degree (Master’s or Ph.D.) in a relevant scientific discipline with a minimum of 4 years of experience with assay development, qualification, and method transfer supporting cGMP operations in biotech/life sciences (Position title commensurate with experience).Experience with mammalian cell culture, aseptic technique, molecular biology (digital PCR, sequencing, etc.), flow cytometry, immunoassays; bioinformatics experience is a plus.Experience writing and performing method qualification/validation protocols, data analysis, performing method transfer, and writing method qualification/validation reports; experience in cell and gene therapy is a plus.Direct experience in activities related to analytical method qualification and/or validation, including designing studies, drafting and executing protocols, analyzing results to define assay performance characteristics based on regulatory guidance and fit-for-purpose best practices, and writing reports.Excellent communication, interpersonal, and leadership skills, with the ability to collaborate effectively with cross-functional teams and stakeholders at all levels.Proven ability to problem-solve, prioritize tasks, and make decisions in a fast-paced and dynamic environment.Experience working in a GMP environment is beneficial.Proficiency in statistical data analysis software (e.g., JMP, GraphPad, Minitab, etc.) and Microsoft Office Suite (Word, Excel, PowerPoint, etc.).

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