Senior Engineer, Plasmid/Nucleic Acids Manufacturing Sciences and Technology
Manufacturing Science and Technology (MSAT) is a department within the Nucleic Acid Business Unit at the Center of Breakthrough Medicines. MSAT provides technical support for enabling manufacturing readiness, robustness and GMP compliance of manufacturing processes for plasmids and other nucleic acid based products. The Senior Engineer of MSAT, Nucleic Acids ensures that technical operations such as fermentation, purification, cell banking, media preparation and buffer preparation are optimized, scalable and compliant through strong collaboration and guidance from Process Development, Quality and Manufacturing teams. This role will be responsible for a combination of technology transfer and scaleup, ensuring GMP compliance, facility design/startup support, and day-to-day technical operational support.
- Lead a team of engineers, scientists, and/or operators, who perform nucleic acid manufacturing.
- Ensure a smooth technology transfer from laboratory to pilot plant to full scale GMP manufacturing while ensuring the effective integration of process knowledge into manufacturing operations.
- Work closely with Manufacturing, Quality, and Process Development teams to ensure that unit operations are thoroughly supported by high quality process documentation (batch records, forms, SOPs, change controls, CAPAs, etc.).
- Responsible for change control ownership, investigations, and other quality system deliverables.
- Support day-to-day plasmid manufacturing operations from early clinical phase through and commercial manufacturing.
- Design and ensure process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
- Support facility standup and facility design to ensure full compliance with GMP standards
- Accountable for process FMEA original drafting and revision through product life cycle.
- Leverage MSAT team’s technical knowledge and expertise to lead investigations from initial analysis, root cause determination to establishment and execution of effective CAPAs.
- Provide on-the floor support during engineering and GMP manufacturing runs. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring.
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 4+ years’ experience, MS with 6+ years, BS with 8+ years
- Proven experience with equipment and manufacturing processes commonly used for fermentation-based bioprocessing.
- Robust experience in technology transfer from development into a cGMP Manufacturing.
- Direct experience of working in quality systems, authoring and review of GMP and technical documents.
- Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
- Thorough understanding of GMP requirements and their relation to process operations.
- Demonstrated project management capabilities.
- Self-motivated with strong interpersonal and organizational skills.
- Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.