CCRM Nordic AB (svb) jobb

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.

About CCRM Nordic CCRM Nordic breaks down the bottlenecks that slow life-changing therapies from lab to patient. Based at GoCo Health and Innovation City in Mölndal, we provide ATMP teams across Sweden, the Nordics and Europe with the infrastructure, know-how and partner network they need, whether that means a single consultation or a long-term manufacturing collaboration. We have invested in a brand-new GMP manufacturing facility with five processing rooms on floor 16 of GoCo House. We are now building the founding team that will shape how this facility runs, and are looking for a Manufacturing Team Lead ready to be part of something genuinely exciting. The opportunity This is a founding role. As one of the first hires into the manufacturing team, you will help build the structure, not just step into it. From authoring SOPs and batch records to training operators and leading quality investigations, this role sits at the operational heart of CCRM Nordic's manufacturing capability. You will lead a team of up to six GMP operators across multiple processing rooms, manage day-to-day scheduling and training, and act as the department's SME for quality systems. You will work alongside PD and MSAT colleagues on new product introductions and technology transfers, and collaborate with our Validation team on equipment qualification and process establishment. Key responsibilities Manufacturing Operations Lead day-to-day GMP manufacturing operations across multiple processing rooms, ensuring clinical materials are delivered on time and to the highest quality standard. Perform and oversee hands-on processing including cell culture, bioreactor operation, Tangential Flow Filtration (TFF) and chromatography. Schedule and manage housekeeping, environmental monitoring and cleaning activities, internally and with external contractors. Maintain full inventory control, ensuring consumables and raw materials are stocked and within expiry. People & Team Leadership Line manage a team of up to six pharmaceutical operators, including performance management, workload planning and day-to-day support. Design and deliver training plans to ensure every team member is qualified for all processing and ancillary activities. Act as a role model for a collaborative, high-performance culture: mentoring and developing the people around you. Quality & Compliance Serve as the manufacturing SME for all GMP quality matters, leading incident investigations, root cause analyses, change controls and CAPAs. Ensure all operations are executed in strict accordance with approved SOPs, Batch Manufacturing Records and current GMP guidelines. Author and review SOPs, batch records, logbooks, COSHH assessments and User Requirement Specifications for new equipment. Support regulatory inspections and ensure the facility is always inspection-ready. Collaborate with the Validation Department on equipment calibration, qualification and shutdown planning. New Product Introduction & Tech Transfer Partner with PD and MSAT teams to introduce new products and processes into the GMP suite. Support technology transfers into and out of the facility, including handovers to clients or CMOs. What we are looking for Essential Minimum 5 years' GMP manufacturing experience, with a strong focus on bioproduction or ATMPs. Proven track record as a line manager of a GMP manufacturing team. Hands-on experience with ATMPs, ideally including Viral Vectors or similar advanced modalities. Degree in bioprocessing, microbiology or a related life science discipline, or equivalent experience. Deep working knowledge of GMP QMS systems: quality incidents, change controls and CAPA management. Experience authoring SOPs, batch records and validation documentation. Strong communication skills and ability to collaborate across functions. Highly Desirable Experience in Tech Transfer and process validation. Hands-on operation of TFF systems, including Repligen platforms. Experience supporting or participating in regulatory inspections. The person We are looking for someone who is: A strong team player who invests in the people around them and understands that great manufacturing is a collective achievement. Adaptable and calm under pressure, able to pivot when processes change, timelines shift or unexpected challenges arise. Energised, not overwhelmed, by the complexity of a new facility and evolving product portfolio. Service-oriented and delivery-focused, with high personal standards for accuracy and thoroughness. An excellent organiser who can hold multiple priorities without letting quality slip. Why join CCRM Nordic? CCRM Nordic is an innovation-led organisation at the frontier of ATMP development. Joining now means helping to shape the team, culture and operational standards of a facility that will directly contribute to getting advanced therapies to patients faster. A rare opportunity to join a founding manufacturing team and leave your mark on how things are built. Work alongside world-class scientists and process development experts on cutting-edge ATMP programmes. A collaborative, supportive environment where your expertise is genuinely valued. Clear pathways for growth as the team expands from Phase 1 through to full multi-project manufacturing capacity. Competitive salary in line with the Swedish pharmaceutical market. Ready to build something important? We'd love to hear from you.