Senior Scientist, CMC Development for ATMPs

CCRM Nordic; Mölndals kommun; On-site; SEK 700,000 - 1,000,000; Full time

Job summary

CCRM Nordic is seeking a Senior Scientist CMC Development to join our growing CMC Development team in Sweden. You will drive process and analytical development for ATMP manufacturing across internal programmes and collaborations with clients and partners.

In this role you will design experiments, transfer processes, and ensure quality and regulatory compliance while collaborating with research, quality, manufacturing and business development teams.

Qualifications

• PhD or equivalent in Bioengineering, Cell and Molecular Biology or related field.
• Minimum five years in biotech/pharma with ATMP experience preferred.
• Experience in process development, cell culture, analytics or related areas.
• Experience managing projects for collaborators or external partners.
• Experience in regulated environments and quality systems.

Responsibilities

• Plan and execute process and analytical development for ATMP manufacturing.
• Design experiments in cell culture, gene engineering, downstream processing and cryopreservation.
• Analyze data, identify trends, and tackle technical challenges.
• Support development and qualification of analytical methods for product quality.
• Collaborate with researchers, development, quality and manufacturing teams.
• Contribute to technology transfer, scale-up, and continuous improvement.
• Prepare protocols, reports, SOPs and development plans.
• Ensure compliance with quality standards and regulatory requirements.
• Manage projects for clients, ensuring timely, high-quality deliverables.

Skills

Process development

Cell culture

Analytical development

Project management

Regulated environments

Problem-solving

Education

PhD or equivalent in Bioengineering, Cell and Molecular Biology or related scientific discipline

Job description

CCRM Nordic is seeking a Senior Scientist CMC Development to join our growing CMC Development team in Sweden. You will drive process and analytical development for ATMP manufacturing across internal programmes and collaborations with clients and partners.

In this role you will design experiments, transfer processes, and ensure quality and regulatory compliance while collaborating with research, quality, manufacturing and business development teams.