Process Development Scientist

Summary

In this role, the Technology Transfer / Process Development Scientist will perform manufacturing process development and technology transfer activities for injectable products to commercial manufacturing lines. The position uses experimental design to establish formulation processes, product pathways, and component selection for successful scale-up. The role provides technical support to Formulation, Filling, and/or Freeze Drying operations within a sterile manufacturing environment and supports studies, commercial scale-up, process validation, and project execution. The position also prepares technical documentation, provides scientific justification, supports technical discussions, and contributes to problem-solving and implementation of technical solutions.

Responsibilities

• Complete studies, technology transfer activities, commercial scale-up, and support process validation.
• Perform manufacturing process development for injectable products.
• Use experimental design to establish formulation processes, product pathways, and component selection for successful scale-up.
• Provide technical support to day-to-day operations in Formulation, Filling, and/or Freeze Drying areas.
• Support technical and scientific process, product, and project activities to implement strategies and technical solutions.
• Assist in the creation of processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches.
• Support technology transfer projects into manufacturing.
• Participate in problem-solving activities related to formulations, equipment, and processes.
• Represent the organization in internal technical discussions.
• Make decisions involving the direct application of technical knowledge.
• Write and revise forms, reports, memos, and protocols.
• Prepare work orders, protocols, summaries, and other project documentation with minimal supervision.
• Provide scientific justification and project status updates as needed.
• Support projects with moderate supervision and implement change control actions.
• Review and plan technical aspects of projects to meet timelines and project goals.
• Support manufacturing operations, change controls, and investigations as a Subject Matter Expert (SME).
• Collect data for statistical analysis and support interpretation and summary of data.
• Support technical discussions with internal and external stakeholders.
• Work on multiple projects simultaneously.
• Maintain awareness of scientific literature and industry trends related to process technologies.

Required Skills

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related physical science.
• Bachelor's degree with 1+ year of related experience, or a related Master's degree.
• Experience in a CDMO or pharmaceutical product development environment is preferred.
• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Detailed knowledge of Good Manufacturing Practices (GMP).
• Prior engineering experience with fill lines is preferred.
• Effective written, interpersonal, and presentation skills.
• Ability to conduct technical discussions with internal and external stakeholders.
• Ability to work on multiple projects simultaneously.
• Ability to acquire knowledge and skills related to pharmaceutical processes, equipment, instrumentation, and procedures.
• Ability to keep current with scientific literature and industry trends related to process technologies.
• Ability to develop and implement technical solutions.
• Ability to apply technical knowledge to decision-making and problem-solving.
• Ability to collect, interpret, and summarize data.
• Ability to work in office, GMP manufacturing, and laboratory environments.
• Ability to stand and walk as required.
• Ability to lift and carry light objects up to 25 lbs. for brief periods.
• Ability to use required PPE during facility activities, client visits, or facility tours.