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Lead Manufacturing Science and Technology Scientist

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Randstad

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Location:
Sweden , Mölndal

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

Looking for an exciting opportunity to shape the future of advanced therapies and help establish Sweden as a leader in Advanced Therapy Medicinal Products (ATMPs)? Consider applying for the Lead MSAT Scientist role at CCRM Nordic and translate breakthrough science into reliable, large-scale manufacturing processes. CCRM Nordic is a non-profit organization established as a national infrastructure to accelerate the commercialization of ATMPs across Sweden and the Nordic region. CCRM Nordic actively bridge the critical gap between academic research and commercial-scale production. They provide specialized expertise, process development services, and are building a state-of-the-art GMP manufacturing facility at GoCo to help innovators translate breakthrough science into safe, scalable, and market-ready treatments. Working at CCRM Nordic means being at the forefront of a high-growth, high-impact field, directly contributing to Sweden’s national ambition to be a global leader in ATMPs and ultimately delivering life-changing therapies to patients.

Job Responsibility:

  • Lead activities for the transition of processes from development into a manufacturing environment to ensure consistent product quality and process robustness
  • Use in-depth knowledge of viral vector biology and/or associated bioprocessing to enable delivery of robust, industrial, closed, GMP-ready processes
  • Lead downstream process operational activities, including establishing unit operations from viral vector harvest to final fill of Drug Substance/Product
  • Lead troubleshooting and resolution of technical issues in manufacturing, including root-cause analysis and implementation of corrective actions
  • Lead and execute process improvement projects to enhance yield, reduce variability, and improve overall performance
  • identify opportunities for optimization and efficiency
  • Collaborate with R&D teams to transfer technologies from early-stage development to manufacturing
  • Author and review technical documents, including protocols, SOPs, reports and regulatory submissions, to support CMC development activities
  • Participate in cross-functional project teams to ensure alignment of CMC development goals with overall project objectives
  • Stay current with advancements in ATMP technologies and contribute to continuous improvement of CMC development strategies
  • Mentor and provide technical guidance to team members, fostering a collaborative and innovative work environment
  • Maintain compliance with regulatory standards and company policies to ensure safety and quality of experimental procedures and products
  • Ensure compliance with regulatory standards, company policies, and safety practices

Requirements:

  • Ph.D. or equivalent in Bioengineering, Chemical Engineering, Molecular Biology, or related field
  • Minimum 5 years’ experience in CMC development/MSAT in biotech/pharma, ideally in cell and gene therapy
  • Strong understanding of process development principles, statistical analysis and QbD concepts
  • Essential: experience with viral vectors used in ex vivo and in vivo product modification
  • Essential: experience with chromatography, filtration and other separation/purification techniques for viral vector bioprocessing
  • Essential: experience of technology transfer to/from commercial and research organizations
  • Experience with analytical methods for characterization and Quality Control of ATMPs (e.g., flow cytometry, qPCR, ELISA, cell-based assays)
  • Essential: experience in the use of QMS
  • Familiarity with regulatory requirements for ATMPs, including cGMP and FDA/EMA regulations
  • A motivation for working closely with Business Development and collaborators to plan, cost and secure projects
  • Excellent communication skills
  • proven ability to collaborate with multidisciplinary teams
  • Proven leadership with a track record of leading projects and mentoring team members
  • Highly organized, detail-oriented, and capable of managing and delivering multiple projects in a fast-paced environment

Additional Information:

Job Posted:
December 26, 2025

Expiration:
December 29, 2025

Employment Type:
Fulltime
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