Scientist II or III - Bioanalytical Assay Support - FSP

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.We are looking to fill a Bioanalytical Scientist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Springhouse, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.ResponsibilitiesDevelop and qualify ligand-binding or cell-based based bioanalytical assays to support high priority biological and vaccine programs.Analyze clinical samples using multiple platforms such as MSD, Luminex, or neutralization assaysAssess analytical result data on acceptability using LIMS or other computer softwareWork according to established Standard Operating Procedures (SOPs) and regulatory guidanceMaintain accurate records of ongoing projects in adherence with ALCOA+ principlesAssist in generation and review of regulated documents and contribute to assay trouble shooting effortsCollaborate and communicate within and across the work groupWork in a structured environment under direct to moderate supervisionAdhere to GxP regulations and safety requirements in BSL-2Qualifications : Degree in Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry, Biology, or related biological science disciplineScientist 2: B.S./B.A. 1-2 years of experienceScientist 3: B.S./B.A. 3-5 years of experience or MS 1-2 years of experienceRequired Skills and ExperienceExperience with immunogenicity assays such as ELISA, Luminex, or MSDWell versed in serology with excellent pipetting skillsWorking experience in a regulated environment (GxP, preferably GLP or GCLP)Strong experience with Laboratory Information Management System (LIMS)Strong computer, scientific, and organizational skillsExcellent communication (oral and written) and attention to detailAbility to work independently and as part of a team, self-motivation, adaptability, and a positive attitudeAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policiesDesired Skills and ExperienceExperience in cell culture and cell-based assaysExperience with Benchling LIMSAbility to manage multiple projects under tight timeline and problem-solving skillsHigh sense of responsibility, accountability, and professional integrityExperience with liquid handlers such as Biomek or end-to-end robotic platforms using MomentumAbout ParexelParexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.Come join us!#LI-DK1EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.SummaryLocation: United States - Pennsylvania - Client OnsiteType: Full time