CMC Lead, Biologics & Vaccine Development

QRIOS; Stockholms kommun; Hybrid; SEK 1,100,000 - 1,600,000; Full time

Job summary

Intervacc AB, headquartered in Stockholm, Sweden, seeks a seasoned CMC Lead to drive the manufacturing and testing for marketed products and to shape the CMC strategy for development of new vaccines.

You will guide regulatory-compliant CMC activities across multiple markets, oversee development and analytical testing, and collaborate with CROs/CMOs and internal teams to ensure timely data delivery and product quality. This is a full-time role in a dynamic biotech environment.

Qualifications

• Required: MSc or PhD in a science-related field (pharmacy, biology or chemistry).
• Significant experience (7–10+ years) in development, manufacturing and analytical testing of biologics or biotechnology-derived products (vaccines).
• Knowledge of drug development and manufacturing for biologics, including upstream/downstream processes and analytics.

Responsibilities

• Provide CMC strategy and expertise for development and marketed products to ensure compliance with global regulatory expectations.
• Deliver CMC parts of development and launch projects and oversee CRO/CMO activities.
• Monitor KPIs and ensure timely data delivery to support development, manufacturing and release.
• Promote Quality by Design and data-driven decision making in CMC work.
• Collaborate with internal functions and external partners to ensure deliverables and resolve issues.
• Participate in budget planning and regulatory inspections support.
• Ensure compliance with regulatory requirements and support inspections.

Skills

CMC leadership

Scientific expertise

Communication in English

Project management

Education

MSc/PhD in science (pharmacy/biology/chemistry)

Job description

Intervacc AB, headquartered in Stockholm, Sweden, seeks a seasoned CMC Lead to drive the manufacturing and testing for marketed products and to shape the CMC strategy for development of new vaccines.

You will guide regulatory-compliant CMC activities across multiple markets, oversee development and analytical testing, and collaborate with CROs/CMOs and internal teams to ensure timely data delivery and product quality. This is a full-time role in a dynamic biotech environment.