Scientist II or III - Bioanalytical Assay Support - FSP

Parexel • United States-Pennsylvania-Remote, PA

3d • Onsite

About The Position

Parexel FSP is seeking a Bioanalytical Scientist to work as a full-time employee on a long-term assignment onsite at one of their clients located in Springhouse, PA. This role involves developing and qualifying bioanalytical assays to support biological and vaccine programs, analyzing clinical samples using various platforms, and assessing analytical data. The position requires adherence to Standard Operating Procedures (SOPs), regulatory guidance, and GxP regulations in a BSL-2 environment. The scientist will maintain accurate records, assist in document generation and review, troubleshoot assays, and collaborate within a work group under direct to moderate supervision.

Requirements

• Degree in Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry, Biology, or related biological science discipline
• Scientist 2: B.S./B.A. 1-2 years of experience
• Scientist 3: B.S./B.A. 3-5 years of experience or MS 1-2 years of experience
• Experience with immunogenicity assays such as ELISA, Luminex, or MSD
• Well versed in serology with excellent pipetting skills
• Working experience in a regulated environment (GxP, preferably GLP or GCLP)
• Strong experience with Laboratory Information Management System (LIMS)
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Nice To Haves

• Experience in cell culture and cell-based assays
• Experience with Benchling LIMS
• Ability to manage multiple projects under tight timeline and problem-solving skills
• High sense of responsibility, accountability, and professional integrity
• Experience with liquid handlers such as Biomek or end-to-end robotic platforms using Momentum

Responsibilities

• Develop 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 assays
• Assess analytical result data on acceptability using LIMS or other computer software
• Work according to established Standard Operating Procedures (SOPs) and regulatory guidance
• Maintain accurate records of ongoing projects in adherence with ALCOA+ principles
• Assist in generation and review of regulated documents and contribute to assay trouble shooting efforts
• Collaborate and communicate within and across the work group
• Work in a structured environment under direct to moderate supervision
• Adhere to GxP regulations and safety requirements in BSL-2

Benefits

• full benefits
• sick time
• 401K
• paid holidays
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level