Scientist, CMC Analytical Sciences

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the analytical development and testing processes required to advance vaccine candidates through the development pipeline.

• Report directly to the Senior Manager, CMC Analytical Sciences.

• Gather, monitor, and analyze analytical testing data from external laboratories.

• Offer technical direction and support to CDMOs and external laboratories.

• Collaborate internally to expedite the progression of assets through development and into commercialization.

• Provide guidance and resolve analytical method challenges.

• Support technology transfer activities between external laboratories and CDMOs.

• Assist in the review and drafting of analytical and stability sections for regulatory submissions.

• Engage in the development of internal systems and standards pertinent to late-phase analytical development.

⛳️ Requirements

• Bachelor’s degree in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, or a closely related discipline; an advanced degree is preferred.

• Direct experience in the development of vaccines, biologics, cell therapies, and/or gene therapies.

• A minimum of 4 years of direct experience in CMC analytical development and/or Quality Control.

• Practical experience in analytical method development and qualification; late-stage experience is preferred.

• Familiarity with cell-based, potency, and infectivity methods; ELISA-based impurity assays; HPLC/UHPLC.

• Understanding of current GxPs and awareness of regulatory and compendial expectations (e.g., ICH, USP/Ph. Eur.) for analytical methods.

• Proven success in a collaborative team environment across various technical functions and geographical locations.

🏝️ 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