CMC Scientist I

We are looking to fill a Bioanalytical Scientist II 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.

Responsibilities

Develop and qualify cell-based or ligand-binding based bioanalytical assays to support high priority biological and vaccine programs.Analyze samples using multiple platforms such as ELISA, ELISPOT, Neutralization assays or flow cytometryAssess analytical result data on acceptability using LIMS or other computer softwareMaintain documentation according to guidelines similar to GxPWork according to established Standard Operating Procedures (SOPs) and regulatory guidanceMaintain accurate records of ongoing projects in adherence with documentation standardsAssist in generation and review of reports and contribute to trouble shooting effortsCollaborate and communicate within and across the work groupWork in a structured environment under direct to moderate supervisionAdhere to GLP regulations and safety requirements in BSL-2

Qualifications : Degree in Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry, Biology, or related biological science discipline

Scientist 1: B.S./B.A. with less than 1 year of experienceScientist 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 experience

Desired Skills and Experience

Working experience in a regulated environment (GxP, preferably GLP)Experience with immunogenicity assays such as ELISA, Luminex, or MSD and/or experience in cell culture and cell based assays such as nAb assays, or ELISPOT assay.Familiarity 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 policiesAbility to manage multiple projects under tight timeline and problem-solving skillsHigh sense of responsibility, accountability, and professional integrity

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

About Parexel

Parexel 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

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