Senior Scientist – Lyophilization & Sterile Process Development

Pfizer; Kansas; Hybrid; USD 99,000 - 165,000; Full time

Job summary

Pfizer seeks an experienced professional to support the design, development, and transfer of sterile pharmaceutical manufacturing processes. You will apply engineering principles to transfer technology from development to manufacturing, evaluate variability, scale-up, and ensure robust and compliant processes.

You will lead lyophilization optimization, participate in process control strategies, and collaborate with Co-Dev, Quality, Validation, and Operations to ensure product quality and supply

Qualifications

• Bachelor's degree with 4+ years of experience; OR a master's degree with 2+ years; OR a PhD with 0+ years; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Experience in Technical Services, MS&T, or pharmaceutical manufacturing
• Demonstrated experience in process development, validation, or technology transfer
• Investigations and troubleshooting of manufacturing processes
• Working knowledge of cGMP and regulatory requirements
• Strong analytical, problem-solving, and communication skills

Responsibilities

• 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.
• Lead or support investigations related to deviations, discrepancies, and process performance issues, including root cause analysis and development of effective CAPA.
• 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.
• 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 process improvements through PAT and changes, and assist in updating technical docs and training operations staff.
• Work with cross-functional teams to provide technical recommendations and solutions for moderately complex problems.

Skills

Analytical thinking

Problem solving

Communication skills

Education

Bachelor's degree + 4+ years

Master's degree + 2+ years

PhD + 0+ years

Associate's degree + 8 years

High school diploma + 10 years

Tools

Digital / AI tools

Job description

Pfizer seeks an experienced professional to support the design, development, and transfer of sterile pharmaceutical manufacturing processes. You will apply engineering principles to transfer technology from development to manufacturing, evaluate variability, scale-up, and ensure robust and compliant processes.

You will lead lyophilization optimization, participate in process control strategies, and collaborate with Co-Dev, Quality, Validation, and Operations to ensure product quality and supply