Key accountabilities/responsibilities for this role include:
• Develop drug product formulations (primarily sterile liquid formulations; solutions/suspensions) for new products, from feasibility to robust formulation definition.
• Define and execute formulation development strategies including excipient screening, compatibility assessments, and formulation robustness work.
• Plan, execute, and document development studies; analyze results and translate data into clear recommendations for next steps.
• Apply QbD principles (e.g., risk assessments/FMEA, design space thinking where applicable) and support DoE-based studies when needed.
• Drive stability strategies and studies (ICH-aligned), interpret stability data, and link outcomes to degradation pathways and formulation improvements.
• Ensure appropriate selection and use of formulation-relevant analytical tools (e.g., pH, osmolality, viscosity, subvisible particles where relevant, moisture where applicable, protein characterization support) and partner with Analytical/Quality teams as needed.
• 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.
• Contribute to scale-down models, comparability approaches, and development rationales supporting decision-making across sites.
• Support CMC documentation and provide technical content for development reports, specifications rationales, and regulatory submissions as applicable.
• Identify, evaluate and implement novel technologies which may be incorporated into the 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.