Senior Manager, CMC RA Vaccines Development Projects

About the role

You will lead Chemistry, Manufacturing and Controls (CMC) activities for vaccine development projects in the United States, working closely with regulatory, clinical, quality, manufacturing and external partners. The role offers growth through complex technical challenges and visible impact on project success.

Key responsibilities

• Develop and execute CMC project plans to support clinical development and regulatory submissions for vaccine candidates.
• Coordinate technical input across quality, manufacturing, analytical development and regulatory functions to ensure timely deliverables.
• Identify, assess and manage CMC risks, creating mitigation plans that protect timelines and regulatory acceptance.
• Prepare, review and approve CMC documentation for regulatory filings and meetings with US health authorities.
• Represent the CMC perspective in cross‑functional project meetings and drive decisions to resolve technical or programmatic issues.
• Mentor and coach team members, supporting capability building across the project team.

Required profile

• Bachelor’s degree in life sciences, engineering, chemistry or a related discipline.
• Minimum 7 years of CMC experience within biologics or vaccines development or manufacturing.
• Experience preparing and managing CMC sections for US regulatory submissions.
• Practical knowledge of manufacturing, quality and analytical development for biologics or vaccines.
• Proven project management skills delivering complex programs with multiple stakeholders.
• Strong communication skills with a track record of influencing cross‑functional teams.
• Advanced degree (MS, PhD) is a plus.

Required skills

• Chemistry, Manufacturing and Controls (CMC)
• Regulatory submissions (US)
• Manufacturing processes for biologics/vaccines
• Quality assurance
• Analytical development
• Project management