Principal Scientist – Lyophilization & Tech Transfer

Pfizer

McPherson (KS)

Hybrid

USD 99,000 - 165,000

Full time

11 days ago

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Benefits offered by this job

Relocation assistance
401(k) with Pfizer Matching Contribu­t
Pfizer Retirement Savings Contribution
Paid vacation, holidays & personaldays

Job summary

Pfizer is hiring a role focused on design, development, transfer, and lifecycle management of sterile manufacturing processes. The candidate will be a subject matter expert for PC1 Lifecycle & Lyophilization, supporting tech transfer, scale-up, process validation, CAPA, and cross-functional projects.

Role requires strong analytical skills, GMP knowledge, and experience in process development and technology transfer; hybrid work arrangement with potential travel.

Qualifications

  • Bachelor’s degree with 4+ years in Technical Services, MS&T, or pharmaceutical manufacturing.
  • Experience in process development, validation, or technology transfer.
  • 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 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.
  • 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 and product improvements, including PAT and evaluation/implementation of changes; develop/update technical documentation and provide training.
  • Work independently or as part of project teams to achieve technical objectives and contribute to moderately complex projects.

Skills

Analytical skills
Problem-solving
Communication skills

Education

Bachelor’s degree + 4+ years experience

Job description

Pfizer is hiring a role focused on design, development, transfer, and lifecycle management of sterile manufacturing processes. The candidate will be a subject matter expert for PC1 Lifecycle & Lyophilization, supporting tech transfer, scale-up, process validation, CAPA, and cross-functional projects.

Role requires strong analytical skills, GMP knowledge, and experience in process development and technology transfer; hybrid work arrangement with potential travel.

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