Background: A Late-Stage Biopharma Preparing for EU Commercialization A mid-sized U.S.-based biopharmaceutical company was preparing to commercialize its first biologic product in the European Union. As part of its global expansion strategy, the company initiated a technology transfer from its U.S. clinical manufacturing facility to a commercial EU site (located in Ireland). While the company

Client: A Biotech CompanyIndustry: Life Sciences / Pharmaceutical ManufacturingSize: 150–200 employeesEngagement Type: Full-service contract staffing partnershipPartner: Assurea Background A rapidly growing biotech company specializing in cell and gene therapy recently secured Series C funding to expand its manufacturing capacity. The organization planned to establish a new biomanufacturing site in New Jersey, aimed at scaling production

Background A mid-sized U.S.-based medical device manufacturer was preparing to initiate a clinical trial for a new Class II device. The company needed additional Clinical Research Associate (CRA) support to oversee trial sites, ensure protocol compliance, and meet regulatory expectations. With limited internal bandwidth and a fast-approaching study start date, the client turned to Assurea’s

Client: Mid-sized biotech company developing novel biologics.Industry: Biotechnology / Life SciencesPositions: 2 QA Specialists and 3 Validation Engineers Background A biotech company was advancing a promising therapeutic candidate through clinical studies toward commercialization. To meet FDA submission timelines, validation of their GMP manufacturing and QC lab equipment and systems had to be completed within six