We are looking to fill a position for a Scientist 3 or Principal Scientist 1 as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. If interested, please send an electronic copy of your resume to donna.kintzley@parexel.com. This position does not offer any sponsorship.

In this position, the candidate will contribute to the reagent characterization and management efforts across the quantitative Bioanalytics and immunogenicity assessment groups that support the development (pre-clinical GLP and clinical studies) of biologics and vaccines.

Responsibilities

• Assist in coordination of critical reagent generation and characterization with internal and external partners to ensure the reagent quality and lot-to-lot consistency. 
• Assist in analytical testing of critical reagents to ensure long term bioanalytical assay robustness using a variety of different analytical tools.  Such assessments include, but are not limited to, binding affinity, stability, and batch-to-batch chromatographic consistency.
• Manage and track reagent life cycles during drug development to ensure adequate reagent supplies are available to support bioanalytical studies. Monitoring/maintaining Reagent Share Point team sites.
• Provide assistance, as needed, to the reagent supports efforts, including but are not limited to reagent aliquoting, RIMS registration, small scale labeling, reagent selection to facilitate method development, etc.

Qualifications:

• Degree in protein biochemistry, molecular biology, immunology, or a related discipline

• Scientist 3:  BS 3-5 yrs. Or MS 1-2 yrs.
• Principal Scientist 1: MS + 3+ yrs. Or Ph.D. 1+ yrs. 

Required Skills and Experience

• Deep knowledge in protein chemistry and hands on experience in protein generation, purification, conjugation, and characterization.
• Understanding and hands-on experiences with analytical assays such as chromatographic assays (e.g., ion-exchange, size exclusion, reversed phase, hydrophobic interaction, etc.), SEC-MALS, LC-MS, CE, cIEF, Biacore/Octet, SDS-PAGE, or related methods for the characterization of antibodies, conjugated proteins, peptides, nucleic acids, etc.
• Basic understanding and experience with ligand binding assays (PK and ADA) or hybrid LC-MS assays in a regulated bioanalytical environment.
• A team player with excellent oral and written communication skills.
• Demonstrate personal commitment with respect to working safely in a laboratory setting

Desired Skills and Experience

• Working knowledge and hands-on experience with vaccine related assay development, will be a plus.

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 FSP

The CMC Operations group is part of Parexel FSP. 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!