Snr. MSAT Process Engineer

About the job Snr. MSAT Process Engineer
Our client is an innovative biotech company in the cell and gene therapy space, to identify a talented and driven Sr. MSAT Process Engineer, to join their growing team!
Are you a seasoned process engineering professional with a passion for cutting-edge therapies and a proven track record in seamlessly scaling innovative processes from development to GMP manufacturing? If so, this could be the perfect opportunity to make a significant impact in a dynamic and entrepreneurial environment.
In this pivotal role, you will:

• Spearhead technology transfer projects for both internal and external collaborations, working closely with Process Development and external partners to ensure smooth and efficient transitions into GMP manufacturing.
• Develop and execute comprehensive technology transfer plans , meticulously adhering to timelines and the highest quality standards.
• Proactively conduct risk assessments and implement robust mitigation strategies to ensure successful technology transfer outcomes.
• Serve as the key technical point of contact for technology transfer discussions between development and manufacturing units (including QA, QC, Supply Chain, Analytical Development), as well as with external clients.
• Take ownership of authoring critical manufacturing documentation , including process descriptions, engineering protocols, technical reports, and material specifications, while also reviewing and approving batch records and other essential transfer-related documents.
• Conduct insightful feasibility and gap assessments , including facility fit analysis, for the introduction of new products and processes.
• Drive continuous improvement initiatives within the MSAT and Manufacturing departments, identifying and implementing innovative solutions to enhance process robustness, scalability, efficiency, and product quality.
• Lead or conduct laboratory work to effectively resolve investigations and provide proof-of-concept for proposed process changes.
• Provide critical process support for manufacturing operations, including leading deviation investigations, performing thorough root cause analyses, and implementing effective CAPAs.
• Play a key role in training manufacturing staff on new processes and technologies.

• A Bachelor's or Master's degree in a relevant scientific or engineering discipline (e.g., Chemical Engineering, Biotechnology, Molecular Biology).
• 5-7+ years of progressive experience in biopharmaceutical process engineering, with a strong emphasis on cell and gene therapy (autologous and allogeneic) processes .
• Demonstrated success in leading technology transfer projects and navigating the complexities of process development and GMP manufacturing.
• Ideally, experience with viral vector manufacturing, cell therapy, and/or mRNA processes.
• Exceptional communication, interpersonal, and project management skills, with a natural ability to collaborate effectively across diverse, cross-functional teams.
• A strong working knowledge of cGMP regulations and relevant regulatory guidelines (e.g., FDA, EMA) , with a consistent track record of ensuring compliance.
• A solid understanding of the lifecycle management of both clinical and commercial manufacturing processes.
• Proven ability to analyze and interpret complex data, drawing meaningful conclusions and contextualizing them within program goals and phase-appropriate requirements.
• A proactive and solution-oriented mindset, thriving in a fast-paced, entrepreneurial environment with broad responsibilities and exciting growth opportunities.