MSAT Process Science Senior Scientist, Investigations

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.