Senior Scientist – Formulation and Pilot Specialist

Role Description Job Description

For the Drug Product Pilot Plant in Louvain-la-Neuve, Belgium, Zoetis is looking for a Senior Scientist – Formulation/Pilot Specialist.

The Senior Scientist – Formulation/Pilot Specialist is responsible for developing and optimizing drug product formulations for new products, supporting new product development projects, and actively contributing to Pilot Plant GMP manufacturing operations. The role requires strong cross-functional collaboration across sites and time zones, and the ability to work autonomously in a development environment as well as hands-on in GMP areas (including Grade A/B). Strong scientific understanding of protein/antigen stability, degradation pathways, excipient selection, and container closure compatibility is expected, along with the ability to translate data into robust and control strategies.

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.

Desired Skills and Experience:

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

•       Proven experience in drug product formulation development (sterile liquid products strongly preferred) within a regulated environment (GMP experience strongly preferred).

•       Strong understanding of biochemistry, degradation pathways, and stabilization approaches for antigens and proteins.

•       Experience in handling protein and vaccine-related formulations (antigens/adjuvants) is a strong asset.

•       Experience with container closure systems, extractables/leachables awareness, and formulation compatibility considerations.

•       Experience with scale-up and tech transfer activities for drug product manufacturing.

•       Exposure to relevant regulatory guidelines and product/process development and registration; ability to contribute to CMC sections/documents.

•       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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