Sabin Vaccine Institute logo
Sabin Vaccine Institute

We are a global health non-profit on a mission to make vaccines more accessible, enable innovation & expand immunization

Scientist, CMC Analytical Sciences

GeneralGeneralFull TimeRemoteSeniorTeam 51-200Since 1993H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$84K - $99K / year

Seniority

Senior

Bachelor Degree4 yrs expEnglish

Job Description

Scientist, CMC Analytical Sciences

Sabin Vaccine Institute

• 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.

Job 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

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