Senior Manager, CMC Analytical Sciences – Remote Vaccines

Sabin Foundation Europe; Only (TN); On-site; USD 145,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Employer‑matching 401(k)

11 federal holidays and winter break

Job summary

Sabin seeks a Senior Manager, CMC Analytical Sciences to direct analytical activities through external CDMOs and labs, ensuring strategies meet regulatory expectations. You will lead method development, validation, and data interpretation across lifecycle stages.

The role requires extensive experience in biologics/vaccines, regulatory submissions, and cross‑functional collaboration, with travel as needed.

Qualifications

• Bachelor’s degree in a pharmaceutical science field.
• 9+ years in biopharma product development and CMC analytics.
• Experience overseeing external labs and CDMOs.

Responsibilities

• Lead development, qualification, validation, and transfer of analytical methods for vaccine substances and products.
• Provide oversight for investigations of OOS/OOT results and CAPAs within CDMOs and external labs.
• Author and review analytical sections of global regulatory submissions (IND, NDA/MAA, BLA) and contribute to CQAs and specification strategies.

Skills

CMC leadership

CDMO oversight

Regulatory submissions

Education

Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science

Job description

Sabin seeks a Senior Manager, CMC Analytical Sciences to direct analytical activities through external CDMOs and labs, ensuring strategies meet regulatory expectations. You will lead method development, validation, and data interpretation across lifecycle stages.

The role requires extensive experience in biologics/vaccines, regulatory submissions, and cross‑functional collaboration, with travel as needed.