Senior Scientist, CMC Development: ATMP Process & Analytics

Ashaphak Wood Works; Mölndals kommun; On-site; SEK 900,000 - 1,300,000; Full time

Job summary

CCRM Nordic seeks a Senior Scientist for CMC Development to drive process and analytical development for ATMP manufacturing. You will design experiments in cell culture, gene engineering, and downstream processing, while collaborating with Q&MS and manufacturing teams to ensure quality and timely deliverables.

The role emphasizes technology transfer, scale-up, and robust documentation, with strong emphasis on regulatory compliance and scientific excellence.

Qualifications

• PhD or equivalent in Bioengineering, Cell and Molecular Biology or related field.
• Minimum of five years of industry experience in biotech/pharma, ATMP development preferred.
• Experience in process development, cell culture, analytical development or related areas.
• Experience in managing projects for collaborators or external partners.
• Experience working in regulated environments and a good understanding of quality requirements.
• Strong scientific, analytical and technical problem-solving capabilities.

Responsibilities

• Plan and execute process and analytical development activities for ATMP manufacturing processes.
• Design and perform experiments related to cell culture, gene engineering, downstream processing and cryopreservation.
• Analyze and interpret experimental data, identify trends and contribute to solving technical challenges.
• Support the development and qualification of analytical methods used to assess product quality and process performance.
• Collaborate closely with colleagues across research, development, quality and manufacturing.
• Contribute to technology transfer, scale-up activities and continuous process improvements.
• Prepare and review technical documentation, including protocols, reports, SOPs and development plans.
• Ensure compliance with applicable quality standards, regulatory requirements and laboratory practices.
• Manage projects for clients and collaborators, ensuring clear communication with stakeholders throughout the project and timely, high-quality deliverables.

Education

PhD in Bioengineering, Cell & Molecular Biology or related

5+ years in biotech/pharma with ATMP focus

Analytical/problem-solving skills

Regulatory/compliance mindset

Tools

Cell culture techniques

Analytical development methods

Technology transfer

Project management

Job description

CCRM Nordic seeks a Senior Scientist for CMC Development to drive process and analytical development for ATMP manufacturing. You will design experiments in cell culture, gene engineering, and downstream processing, while collaborating with Q&MS and manufacturing teams to ensure quality and timely deliverables.

The role emphasizes technology transfer, scale-up, and robust documentation, with strong emphasis on regulatory compliance and scientific excellence.