Scientist, CMC Analytical Sciences

🕒 June 26

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• Support the analytical development and testing activities necessary to advance vaccine candidates through the development pipeline. • Report to the Senior Manager, CMC Analytical Sciences. • Collect, monitor, and interpret analytical testing data from external laboratories. • Provide technical direction and guidance to CDMOs and external labs. • Collaborate internally to progress assets swiftly through development and into commercialization. • Provide guidance and troubleshoot analytical method issues. • Support tech transfer activities between external labs/CDMOs. • Provide review and authoring support for analytical and stability sections of regulatory submissions. • Participate in the development of internal systems and standards related to late-phase analytical development.

🎯 Requirements

• Bachelor’s degree in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, or a closely related field; advanced degree preferred. • Direct experience in the development of vaccines, biologics, cell therapies, and/or gene therapies. • Minimum of 4 years of direct experience in CMC analytical development and/or Quality Control. • Hands-on experience in analytical method development and qualification; late-stage experience is preferred. • Experience with cell-based, potency, and infectivity methods; ELISA-based impurity assays; HPLC/UHPLC. • Knowledge of current GxPs and familiarity with regulatory and compendial expectations (e.g., ICH, USP/Ph. Eur.) for analytical methods. • Successful experience in a collaborative team environment across multiple technical functions and geographical regions.

🏖️ Benefits

• medical, dental, and vision coverage • flexible spending accounts • flexible vacation and sick leave • employer-paid life and disability insurance • 11 federal holidays • end-of-year winter break • employer-matching 401(k) plan