Principal Scientist

ROLE SUMMARY

Accountable for supporting activities involved in the design, development, transfer, and lifecycle management of manufacturing processes for sterile pharmaceutical products. The candidate selected will be a subject matter expert for PC1 Lifecycle & Lyophilization.

Applies scientific and engineering principles to support the transfer of technology from development into manufacturing, including evaluation of process variability, scale-up considerations, and operational constraints. Contributes to the development of robust, compliant, and scalable manufacturing processes, including new or revised process designs. Designs and executes experimental studies, analyzes process performance, and supports process control strategies to ensure consistent product quality. Serves as a technical resource for process-related issues, supporting troubleshooting efforts and resolving moderately complex manufacturing and equipment-related problems.

Operates as a strong individual contributor, applying comprehensive knowledge of the discipline, working independently on routine activities, and exercising judgment to resolve moderately complex problems while receiving guidance on more complex challenges.

• Support the design, development, evaluation, and implementation of new or revised manufacturing processes in collaboration with Co-Dev teams and manufacturing operations.
• Design and execute experimental protocols, studies, and measurements to evaluate process performance, variability, scalability, and control of critical process variables.

• Conduct laboratory and engineering studies and analyze data to support product understanding, process performance, technical decision-making, and process improvements.
• Author and review technical reports and provide input on product characterization and analytical methodologies, ensuring scientific rigor and inspection readiness.

• Lead or support investigations related to deviations, discrepancies, and process performance issues, including root cause analysis and development of effective CAPA.
• Troubleshoot and resolve process and equipment-related challenges in commercial manufacturing while serving as a scientific and technical representative for facility process issues.

• Support end-to-end lifecycle activities for PC1 products, including technology transfer, scale-up, process validation, CPV monitoring, change control, and post-approval change implementation.
• Develop technical impact assessments, support change execution plans, and collaborate cross-functionally to ensure process robustness, compliance, supply continuity, and continuous improvement.

• Serve as a Technical Services SME for lyophilization, providing technical support for cycle understanding and optimization, equipment capability, process performance evaluation, and troubleshooting of lyo-related product or process issues.
• Support development of process understanding and control strategies for lyophilization operations.

• Support process and product improvements, including application of process analytical technologies (PAT) and evaluation and implementation of process, equipment, and system changes.
• Assist in developing and updating technical documentation and procedures, and provide technical support and training to operations and technical staff.

• Work independently or as part of project teams to achieve technical objectives and contribute to moderately complex projects impacting the department.
• Provide technical recommendations and solutions for moderately complex problems in collaboration with Operations, Quality, Validation, and Engineering.

• Applicant must have a bachelor’s degree with at least 4 years of experience; OR a master’s degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate’s degree with 8 years of experience; OR a high school diploma (or…