Overview

Repligen Corporation (NASDAQ: RGEN) is a life sciences company focused on the development, production, and commercialization of high-value consumable and system products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.

We are seeking an experienced, highly motivated, resourceful, detail-oriented assay development scientist.   This scientist will play a lead role in the design and development of ELISA based affinity ligand detection kits in support of Repligen’s affinity chromatography business.  

Responsibilities

• Provide technical oversight of Immunoassay/ ELISA based development projects while maintaining active participation within the lab
• Design and develop ELISA based assays for the detection of residual affinity ligand following affinity chromatography
• Assay design and development including antibody selection, conjugation of reagents, plate coating methods and chemistries, sample preparation and handling, data analysis methodologies
• Design and perform experiments to demonstrate feasibility and characterize performance and robustness (dynamic range, limit of detection, spike and recovery, precision, accuracy, and assay linearity) of ELISA based assays
• Provide data driven updates and collaborate with ELISA Manufacturing and QC teams throughout the product development process
• Provide technical support and guidance to end users for new and established ELISA based products which includes troubleshooting, root cause analysis, process improvement.
• Document experimental results and development data; provide internal oral and written presentations, author technical reports, user guides and application notes
• Work collaboratively across departments and teams. Manage, train and mentor junior staff

Qualifications

• Degree in Analytical Chemistry, Biochemistry, or related life science field with proven hands-on experience
• BS/MS with 5+years or Ph.D. with 2+ of relevant industrial experience in an application or product development setting
• Expertise in the design and development of robust and reproducible commercial ELISA based assays with an understanding of product tech transfer processes
• Extensive knowledge of characterization and qualification techniques utilizing ICH guidelines for analytical assays
• Well versed in a variety of biochemistry and analytical techniques such as protein purification by column chromatography, protein conjugation, HPLC/MS, SDS-PAGE, Western-Blot, PCR, Endotoxin, Bioburden, and cell-based assays
• Strong analytical and problem-solving skills, with demonstrated knowledge of statistical methodologies including DoE
• Experience working within a cGMP/ GLP, and ISO regulated quality system
• Ability to work independently and multi-task and be highly productive in a collaborative environment