Remote Senior CMC Technical Operations Manager - Vaccines

Sabin Foundation Europe; Only (TN); On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Flexible spending accounts

Flexible vacation and sick leave

Disability options

10 federal holidays + winter break

401(k) plan

Job summary

Sabin Foundation Europe seeks a Senior Manager, CMC Technical Operations to drive end-to-end CMC support for Sabin’s vaccine programs from the clinic through regulatory submission. You will guide cross-functional teams and coordinate external partners to align with development plans.

You will lead documentation for IND/BLA filings, ensure regulatory readiness, and manage CMC activities within budget constraints. Remote role with global collaborators, travel up to 15% may be required.

Qualifications

• Bachelor’s degree in a related field; advanced degree preferred.
• 10+ years direct experience with CMC product & process development.
• Experience with cGMP, ICH guidelines, and regulatory submissions.
• Ability to lead in a matrix, with strong communication skills.

Responsibilities

• Serve as cross-functional team member for end-to-end CMC integration.
• Collaborate across CMC functions to deliver on time and on budget.
• Assist with alliance management and development strategy.
• Provide technical guidance across CMC elements (drug substance/product).
• Support regulatory submissions (IND, BLA/MAA) and information requests.
• Prepare documentation for funding efforts and manage QMS docs.
• Communicate updates to internal and external stakeholders.

Skills

Project management

Writing & presentation

Interpersonal skills

Independent work

Education

Bachelor's degree, biochemical eng

Advanced degree preferred

Job description

Sabin Foundation Europe seeks a Senior Manager, CMC Technical Operations to drive end-to-end CMC support for Sabin’s vaccine programs from the clinic through regulatory submission. You will guide cross-functional teams and coordinate external partners to align with development plans.

You will lead documentation for IND/BLA filings, ensure regulatory readiness, and manage CMC activities within budget constraints. Remote role with global collaborators, travel up to 15% may be required.