Scientist, CMC Analytical Sciences

About the role

The Scientist, CMC Analytical Sciences supports the analytical development and testing activities necessary to advance vaccine candidates through the development pipeline. They provide technical direction and guidance to Contract Development and Manufacturing Organizations (CDMOs) and external laboratories, collaborate internally to progress assets swiftly through development and into commercialization, and manage samples and standards.

Responsibilities

• Collect, monitor, and interpret analytical testing data from external laboratories to ensure accuracy, completeness, and compliance with applicable regulatory and ICH guidelines.
• Provide technical direction and guidance to CDMOs and external labs.
• Collaborate internally to progress assets swiftly through development and into commercialization.
• Provide guidance, troubleshoot analytical method issues, and recommend corrective actions in collaboration with CDMO and contract lab personnel.
• Support tech transfer activities between external labs/CDMOs.
• Provide review and authoring support, as needed, for analytical and stability sections of vaccine candidate regulatory submissions.
• Provide direct oversight and responsibility for the execution of compliant stability programs.
• 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.
• Ideal candidate will have knowledge of adenoviral vector manufacturing and testing methods.
• Minimum of 4 years of direct experience in CMC analytical development and/or Quality Control, with direct experience with method qualification/validation and transfer, and management of analytical activities at CDMOs and outside test labs (OTLs).
• 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; titer methods, compendial methods, excipient quantitation, RT-PCR, laser light scattering.
• Method transfer and troubleshooting experience.
• Knowledge of current GxPs and familiarity with regulatory and compendial expectations (e.g., ICH, USP/Ph. Eur.) for analytical methods.
• Experience in deviation management and corrective/preventive action implementation.
• Successful experience in a collaborative team environment across multiple technical functions and geographical regions, including experience working across various CMC functions to develop assets.
• Ability to work independently with minimal direct oversight and also collaboratively with globally distributed team members.
• Ability to work remotely and travel up to 20% (USA and international) to support onsite activities at outside test labs (OTLs) and CDMOs.

Qualifications

• Passport required for international travel.

Skills

• Strong scientific depth in analytical chemistry and/or biochemistry.
• Comfort working in a fully outsourced model.
• The ability to operate independently in a fast-paced, resource-constrained nonprofit environment.

Benefits

Sabin provides a comprehensive benefits package that includes medical, dental, and vision coverage, as well as flexible spending accounts. Eligible employees receive flexible vacation and sick leave, along with employer-paid life and disability insurance. The organization observes 11 federal holidays and an end-of-year winter break. Sabin also offers an employer-matching 401(k) plan.

Pay

$84,000 - $99,000 annually, depending on skills, experience, training, and certifications/degree.

Schedule

Full-time, remote worker, US Only.