Key accountabilities/responsibilities for this role include:
• Develop lyophilization (freeze-drying) cycles and methods for new products, from feasibility to robust process definition.
• Plan, execute, and document development studies; analyze results and translate data into clear recommendations for next steps.
• Provide at least theoretical mastery of core lyophilization-related equipment and analytical tools (e.g., freeze-dryer operation principles, product probes such as Tempris, Karl Fischer moisture, DSC, electron microscopy) and ensure appropriate use in development work.
• Own and manage a development area in autonomy, including organization, equipment readiness, and good documentation practices.
• Represent the Pilot Plant / LLN in development meetings with stakeholders from R&D, Quality, and other functions; communicate progress, risks, and decisions clearly.
• Lead project development and transfer aspects of new product (scope, timelines, deliverables, meeting cadence, and action follow-up) in a multi-site environment.
• Identify, evaluate and implement novel technologies which may be incorporated into expertise area
Pilot Plant GMP manufacturing support:
• Actively participate in Pilot Plant production operations, including routine presence and work in GMP areas.
• Responsible for the drug product scale-up and tech transfer activities
• Coordinates technical transfer activities and the use of manufacturing facilities for VMRD functions, including production of PLS/VICH drug product batches
• Perform GMP gowning and follow GMP behaviors and requirements (cleaning, environmental monitoring awareness, and compliance with procedures).
• Complete the required qualification and be able to enter and work in Grade B areas, in line with site training and qualification requirements.
• Support production activities such as material preparation, equipment preparation/assembly, cleaning and sterilization, tank cleaning, and execution of unit operations.
• Contribute to formulation activities in GMP and non-GMP environments, including activities linked to graded areas.
• Work under RABS when applicable and support filling activities, including hands-on work on a graded filling line within GMP areas.