MSAT Senior Scientist
About The Position
The MSAT Senior Scientist is a key individual contributor responsible for leading technical initiatives in support of aseptic fill-finish operations at the Lonza GMP manufacturing site in Walkersville, MD. This role is highly focused on supporting and optimizing fill line operations, including qualification of fill lines, technical transfer of products, and ensuring process readiness for new product introductions. The individual will execute qualification protocols, troubleshoot equipment performance, and provide specialized technical expertise across integrated fill line systems to maintain throughput, ensure aseptic control, and respond effectively to operational deviations. This individual will serve as a subject matter expert (SME) in aseptic manufacturing, supporting vial, bottle, and/or bag filling operations, and will play a critical role in aseptic process simulations (APS/media fills) and cleaning validation programs. Responsibilities include authoring and reviewing protocols, executing studies, evaluating results, and ensuring compliance with regulatory expectations while maintaining inspection readiness. The role requires strong cross-functional collaboration with Manufacturing, Quality, R&D, and Supply Chain to ensure safe, compliant, and efficient GMP operations.
Requirements
- Bachelor’s or advanced degree in a relevant scientific or engineering discipline
- 4+ years of experience in aseptic fill-finish operations, including vial, bottle, or bag filling (multi-line experience preferred)
- Strong hands-on experience with aseptic processing and cleanroom operations (Grade A/B environments)
- Direct experience leading or supporting APS (media fills), including execution, intervention design, and contamination investigations
- Deep understanding of sterility assurance principles and regulatory expectations (FDA, EMA) for aseptic manufacturing
- Proven experience in process validation (PPQ) and lifecycle management within fill-finish operations
- Strong technical writing skills with experience authoring APS, validation, and investigation documents
- Experience with root cause analysis tools (e.g., Fault Tree Analysis, Causal Branching, Event & Causal Factor Charting)
- Proficiency in statistical/data analysis tools (JMP, Minitab, or similar)
- Ability to interpret P&IDs, process flows, and fill line equipment design
- Strong troubleshooting skills within live GMP aseptic manufacturing environments
- Demonstrated ability to collaborate cross-functionally and influence stakeholders
- Hands-on, detail-oriented, and action-driven mindset with strong ownership
- Strong understanding of GMP compliance and aseptic regulatory expectations
Responsibilities
- Serve as SME for aseptic fill-finish operations, providing direct support to vial, bottle, and/or bag filling lines
- Lead and support Aseptic Process Simulations (APS/media fills), including protocol design, execution oversight, troubleshooting, and report authoring
- Drive sterility assurance strategy and ensure compliance with aseptic processing standards and regulatory expectations
- Lead technical projects including tech transfer, process validation (PPQ), cleaning validation, and APS
- Provide real-time floor support for fill line operations, including troubleshooting interventions, equipment issues, and process deviations
- Conduct complex investigations related to aseptic processes, contamination risks, and fill line performance, utilizing structured root cause analysis tools
- Author and review GMP documentation including: APS (media fill) protocols and reports Process Performance Qualification (PPQ) Cleaning validation documentation Deviation and investigation reports Engineering studies and technical assessments
- Monitor and trend aseptic process performance, including critical parameters and environmental monitoring data
- Perform process data analysis using statistical tools to identify trends, risks, and opportunities for improvement
- Partner closely with Manufacturing and Quality to support interventions, line qualifications, and aseptic best practices
- Support tech transfer activities for new products/processes into fill-finish operations, including facility fit assessments and gap analyses
- Lead or support equipment qualification activities (FAT/SAT, IQ/OQ/PQ) for fill line systems and associated technologies
- Manage Deviations, CAPAs, and Change Controls as SME within GMP quality systems
- Identify and implement process improvements to enhance aseptic robustness, reduce contamination risk, and improve operational efficiency
- Train and mentor manufacturing personnel on aseptic techniques, interventions, and best practices
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- 401(k) matching plan.
- Life insurance, as well as short-term and long-term disability insurance.
- Employee assistance programs.
- Paid time off (PTO).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
