Senior Scientist – Lyophilization and Pilot Specialist

• 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.

Desired Skills and Experience:

• Master’s degree (or PhD) in Pharmaceutical Sciences, Chemistry, Biotechnology, Biomedical Engineering, Chemical Engineering, or related field.

• Proven experience in lyophilization process development and/or sterile product development within a regulated environment (GMP experience is strongly preferred).

• Understanding of biochemistry, degradation pathways, and general approaches for antigen and protein stabilization

• Experience in handling protein formulations

• Expertise with liquid and lyophilized drug product scale-up, tech transfer activities

• Exposure to relevant regulatory guidelines and product/process development and registration

• Well-versed with Quality and EHS requirements

• Ability and willingness to perform hands-on activities in GMP areas, including the requirements associated with working in graded areas (up to and including Grade B).

• Strong scientific rigor: experimental design, data interpretation, and clear technical writing/documentation.

• Project mindset: ability to manage priorities, timelines, and stakeholders across multiple sites and time zones.

• Strong collaboration and communication skills; comfortable interacting with scientific and Quality stakeholders.

• Autonomous, structured, and safety/quality minded in daily execution.

• Fluent in French and English

• Demonstrated problem solving skills and ability to perform in a team-based environment.

Interested ?

If you are interested in this opportunity, please apply through the local/internal recruitment process and share your CV according to the LLN site guidelines.

Full time

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