Principal Scientist

Pfizer; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Pfizer seeks a scientist/engineer to design, develop, transfer and manage sterile manufacturing processes. The role centers on PC1 Lifecycle & Lyophilization, applying engineering principles to transfer development to manufacturing.

The candidate will design experiments, analyze data, support process control strategies, and troubleshoot moderately complex manufacturing issues while collaborating with cross-functional teams to ensure quality, compliance, and supply continuity.

Qualifications

• Bachelor's degree with 4+ years of experience, or Master's with 2+ years, or PhD with 0+ years, or Associate's with 8 years, or HS diploma with 10 years.
• Experience in Technical Services, Manufacturing Science & Technology (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 design, development, evaluation, and implementation of new or revised manufacturing processes with Co‑Dev teams and operations.
• Design and execute experimental protocols to evaluate performance, variability, scalability, and control of critical variables.
• Conduct laboratory and engineering studies and analyze data to support product understanding and decisions.
• Lead or support investigations, root-cause analysis, and CAPA development.
• Support end-to-end lifecycle activities for PC1 products including tech transfer and scale-up.
• Serve as Lyophilization SME for cycle understanding, optimization and troubleshooting.
• Develop technical documentation and procedures; provide training to staff.

Skills

Analytical skills

Problem solving

Communication skills

Independent worker

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Master's degree in a related field

PhD in a relevant field

Job description

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.

ROLE RESPONSIBILITIES

Process Design, Development & Technical Execution

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.

Scientific Studies & Data Analysis

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.

Investigations, Troubleshooting & Problem Solving

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.

PC1 Product Lifecycle Management

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.

Lyophilization SME (Lyo) Support

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.

Process Improvement & Change Management

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.

Cross‑Functional Collaboration & Project Contribution

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.

BASIC QUALIFICATIONS

• 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 equivalent) and 10 years of relevant experience.
• Experience in Technical Services, Manufacturing Science & Technology (MS&T), or pharmaceutical manufacturing
• Demonstrated experience in: Process development, validation, or technology transfer
• Demonstrated experience in: Investigations and troubleshooting of manufacturing processes
• Demonstrated experience in: Working knowledge of cGMP and regulatory requirements
• Strong analytical, problem‑solving, and communication skills

PREFERRED QUALIFICATIONS

• Experience supporting product lifecycle management activities (CPV, change control, Post Approval Changes)
• Experience with sterile injectable manufacturing processes
• Experience with lyophilization process development or troubleshooting
• Experience working in cross‑functional and project team environments
• Familiarity with digital or AI tools to support da