Role Summary
CMC Development Technician
Location: CCRM Nordic AB, Mölndal
About the role
As a CMC Development Technician, you will support process and analytical development activities that advance novel therapeutic approaches. You’ll work hands-on to optimize, characterize and scale manufacturing processes for cell and gene therapy products, collaborating closely across teams.
Key responsibilities
- Support the execution of process and analytical development activities for the optimization, characterization and scale-up of manufacturing processes.
- Aid the design and execution of experiments to evaluate and improve cell culture processes, gene engineering techniques, and/or downstream purification methods.
- Contribute to the development and implementation of robust analytical assays to monitor critical quality attributes of therapeutic products and (critical) raw materials.
- Receive, generate, label, and analyze samples following defined procedures.
- Produce and record data, troubleshoot technical challenges, and propose innovative solutions to enhance process efficiency and product quality, using excellent communication skills.
- Collaborate with research and development teams to transfer technologies from early-stage development to manufacturing.
- Organize and store chemicals and consumables according to safety instructions and procedures defined by development teams and the Lab Manager.
- Author and review technical documents, including protocols, reports, instructions, SOPs and URS to support CMC development and Quality activities.
- Participate in relevant cross-functional projects to align CMC development goals with internal and external project objectives, fostering a collaborative and innovative work environment.
- Keep up to date with relevant scientific literature and technology platforms, and contribute to and publish scientific content.
- Contribute to equipment maintenance and assist in ordering laboratory supplies in cooperation with the development team and Lab Manager.
- Maintain compliance with regulatory standards and company policies/SOPs, ensuring the safety and quality of experimental procedures and therapeutic products.
Education & Experience
- M.Sc. or bachelor’s degree in Bioengineering, Chemical Engineering, Molecular Biology, or related field.
- Relevant experience in process development/manufacturing or Quality Control in biotech/pharma; cell & gene therapy preferred.
- Experience in mammalian cell culture techniques and related operations/processes.
- Knowledge of editing technologies such as CRISPR/Cas9 or lentiviral vectors (LVVs) and their uses in manufacturing of therapies.
- Experience with analytical methods for characterizing cell-based products (e.g., flow cytometry, PCR, ELISA, cell-based assays).
- Awareness of regulatory requirements for cell and gene therapy products, including cGMP and FDA/EMA regulations.
- Working knowledge of MS Office and defined systems/software.
Personal Attributes
- Quality-driven, eager to learn, and open to new concepts such as Quality by Design (QbD).
- Excellent communication skills; able to collaborate effectively with multidisciplinary teams.
- Highly organized, detail-oriented, and capable of managing multiple tasks in a dynamic environment.
