Formulation & Process Principal Scientist

• ensures the development of pharmaceutical products (injectable and oral forms) by developing the formulations, selecting the primary packaging and defining the drug product manufacturing process.
• performs his / her mission according to (i) the up-to-date internal and external regulatory guidance and process, (ii) and within time, resources and cost agreed by the company.

• Based on the Quality Target Product Profile, propose and justify the formulation and process development strategy suitable to the development stage, from candidate validation to drug product launch,
• Define and plan development studies to be performed internally in the formulation lab in collaboration with the analytical team,
• Ensure the on-time availability of the documents required for his/her activities, i.e. protocols, reports, batch records,
• Present the results and progress of projects under his/her responsibility at internal technical meetings,
• Manage the transfer and scale-up of the drug product manufacturing process either internally or at the CMOs, and lead the manufacturing of technical and formal stability campaigns,
• Ensure a suitable technical transfer to the DP Manufacturing team and provide continuous support to the manufacturing of clinical batches,
• Pilot activities related to drug product process validation,
• Manage Drug Product CDMOs: set up contracts and Quality Technical Agreements, organize regular meetings and steering committees, monitor performance through KPIs, control the budget,
• In collaboration with the Operational Quality Assurance team, ensure the review of the batch records and instructions of technical and stability batches and manage the quality events in line with defined KPIs,
• Develop/maintain a network of efficient subcontractors to ensure his / her activities,
• Represent the Formulation & Process function in CMC project meetings and ensure full alignment and adequate communication with the CMC lead,
• Be involved strongly in the CMC sections writing of the IMPD, IND, NDA and MAA and guarantee the technical reliability and accuracy of submitted data,
• Ensure regulatory surveillance related to his / her activities,
• Contribute to the development of strong technical skills and expertise in the Formulation team to enable rapid development of products, within the appropriate Quality framework (Quality Risk Management),
• Ensure the suitable application of Quality by Design principles from the early stage of the development to the Drug Product dossier filling,
• Makes valuable contributions to scientific literature and be seen as a company expert at internal/external scientific conferences,
• Guarantee a continuous improvement process and knowledge management within the Formulation and Process function,
• Develop and optimize the Formulation & Process team’s interfaces.

• Contribute to continuous improvement projects within the Formulation, Process and Clinical Supply Department and/or wider Pharmaceutical Development.
• Be a promoter of continuous improvement processes and to guarantee the method.

• Strong experience and knowledge on GMP and cGMP,
• Excellent communication skills,
• Experience in project management,
• Experience in CDMO management,
• Team player with ability to work in a matrix environment,
• Strong organizational skills.

• Pharmacist, engineer, degree in science or equivalent, ideally with a PhD in science

• 7-10 years’ experience in an equivalent job in the Pharmaceutical Industry with a significant international exposure

• Fluent in English to effectively interface with English-speaking subcontractors

Ipsen