Role Summary
Lead MSAT Scientist
Location: GoCo, Mölndal
Department: CMC Development
About the role
As Lead MSAT Scientist, you will provide hands-on leadership and expertise in transitioning process development into a manufacturing environment. You will focus on delivering viral vector production platforms and on the optimization, analysis, characterization and transfer of manufacturing processes for ATMPs—ensuring robustness, scalability and compliance.
Key responsibilities
- 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
Education & Experience
- 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.
Personal Attributes
- 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.
