Senior Scientist CMC Development

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

Senior Scientist CMC Development

At CCRM Nordic, we're advancing innovative cell and gene therapies from development to clinical and commercial manufacturing. We're now looking for a Senior Scientist CMC Development to join our growing CMC Development team.

The role

In this role, you'll contribute to the development of advanced therapy medicinal products (ATMPs) by driving process and analytical development activities across a range of internal programmes and projects run with external clients and collaborators.
Working in a highly collaborative environment and utilizing cutting-edge technologies in our CMC Development Laboratory, you'll help develop, optimize and transfer manufacturing processes for advanced therapies. Through this work, you'll contribute to bringing innovative treatments closer to patients.

Key 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.

What we're looking for

• PhD or equivalent experience in Bioengineering, Cell and Molecular Biology or a related scientific discipline.
• Minimum of five years of industry experience within the biotechnology and pharmaceutical industries, with a focus on 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.

Preferred qualifications

Additional expertise in one or more of the following areas is considered advantageous:

• Good knowledge of cell and gene therapy technologies and experience in Chemistry, Manufacturing, Controls (CMC) development.
• Good knowledge of immuno-oncology and hands-on experience with various immune cell types, e.g., NK cells, monocytes, and macrophages.
• Hands-on experience with in vivo CAR-T workflows, including CAR transfection/transduction, CAR protein expression, and potency and functionality assays.
• Hands-on experience with closed, automated, and scalable cell processing systems for isolation, gene engineering, expansion, harvest, formulation, and cryopreservation.

The person

We're looking for a collaborative and curious scientist who enjoys working at the intersection of innovation, technology and product development.

You thrive in a dynamic environment where priorities can evolve, and you're comfortable taking ownership of your work while supporting the wider team. You will work closely with experienced scientists, CMC and quality experts, manufacturing operators and the business development team.

You're a structured, detailed-oriented, and proactive communicator who enjoys spending time in the lab, sharing knowledge, solving complex challenges and contributing to a positive team culture.

Why join CCRM Nordic?

At CCRM Nordic, you'll have the opportunity to work at the forefront of cell and gene therapy development alongside talented colleagues who are passionate about making a difference.

We offer a collaborative and purpose-driven environment where scientific excellence, innovation and teamwork are valued. As we continue to grow, you'll have the opportunity to influence how therapies are developed and help bring new treatments closer to patients.