MSAT Process Science Senior Scientist, Investigations

General Summary:

The MSAT Senior Scientist (Investigations and Strategic Projects) is responsible for leading complex technical investigations, driving strategic process improvements, and fostering a culture of continuous improvement within manufacturing operations. This role will leverage Six Sigma methodologies, including DMAIC, and lead complex technical investigations utilizing statistical methods and multivariate analysis to understand and identify contributing factors influencing manufacturing outcomes. In addition, this position will drive strategic improvement initiatives across manufacturing operations as a form of continuous improvement. The incumbent will collaborate cross-functionally with Quality, Engineering, Manufacturing, Process Development and Regulatory teams to ensure robust root cause analysis (RCA), effective corrective and preventive actions (CAPAs), and sustainable process improvements are deployed that align with business and regulatory expectations.

Key Duties and Responsibilities:

• Lead and manage high-impact technical investigations, applying structured problem-solving methodologies such as DMAIC to ensure thorough root cause analysis and CAPA implementation.
• Act as a subject matter expert (SME) in major investigations related to deviations, out-of-specifications (OOS), or out-of trends (OOT), and process failures, ensuring alignment with regulatory expectations.
• Utilize a data-driven approach to investigations, leveraging statistical analysis and multivariate data analysis to identify root cause, systemic issues and identify options to prevent recurrence.
• Develop and present investigation reports to senior leadership and regulatory agencies as needed.
• Lead strategic improvement projects focused on improving process control, process efficiency, and manufacturing robustness using DMAIC principles.
• Identify, prioritize, and execute initiatives that reduce process variability, increase yield, and enhance compliance through data-driven decision-making.
• Collaborate with cross-functional teams to implement innovative solutions, integrating Lean and Six Sigma methodologies to drive sustainable improvements.

Knowledge and Skills:

• Previous experience working in a highly matrixed environment.
• Extensive experience with cell and gene therapy, biologics process development and cGMP manufacturing.
• Strong documentation skills to support risk analysis, protocol development, and report documentation.
• Experience with cGMP regulations/guidance and regulatory agency inspections.
• Experience authoring/reviewing CMC product submissions and post-approval changes.
• Experience with continuous improvement, proficiency with operational excellence preferred.
• Experience working with external manufacturing partners (CDMOs/CMOs), suppliers, and service providers.
• Ability to travel, nationally and internationally, up to 10%.
• Flexibility to work on site a minimum of 3 days per week.

Education and Experience:

• Bachelor’s, Master’s, or Ph.D. in Engineering, Biotechnology, Biochemistry, or a related scientific field.
• 5-7+ years of experience in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment, with a focus on MSAT, process investigations, and improvement initiatives.
• Strong expertise in Six Sigma methodologies, including DMAIC; Lean Six Sigma Yellow Belt,/ Green Belt preferred.
• Demonstrated experience leading major investigations and implementing effective CAPAs in a regulated environment.
• Proficiency in statistical tools (JMP, Statistica, etc.) and data-driven decision-making to drive process optimization.
• Proven ability to work within cross-functional teams and manage multiple high-impact projects simultaneously.
• Strong communication and presentation skills, with experience delivering technical reports and presentations to development teams, senior leadership, and regulatory bodies.
• Experience working with external manufacturing partners (CDMOs/CMOs), suppliers, and service providers.

​Preferred Qualifications:

• Experienced with advanced analytics and digital tools.
• Lean Six Sigma Yellow belt, Green Belt or Black Belt certification.
• Experience with technology transfer, scale-up, and process validation activities.