Jerome Le Cunff Email & Phone Number

Zagreb, Croatia

Zagreb, Grad Zagreb, Croatia

- Serve as a key scientific and technical representative for process-related issues at Xellia sites as well as third party manufacturing sites. Participate in collection and interpretation of data, and collaborate with other departments on all manufacturing related issues to drive issue resolution- Support root cause investigations by providing technical intelligence to deviations, technical complaints, OOS & CAPAs- Safeguard, maintain and develop the scientific database of Xellia products and manufacturing processes- Support R&D projects during process development, technology transfer and process validation to ensure a robust commercial scale-up and timely launches of new products- Assess technological suitability/fit of a potential manufacturing site for production of specific FDF product, identifying any gaps in technology and equipment and evaluate activities and investments needed to assure technology fit- Support the identification and implementation of new technologies - Partner with Regulatory Affairs and R&D to support submissions and approval of new product applications- Propose and support FDF technological improvement initiatives (eg. continuous improvements, CI) in the commercial phase of the product lifecycle- Lead process optimization activities, manage experimental work in cooperation with R&D and the manufacturing sites (plan, design, perform and lead experimental work accordingly) and report results according to department and project plans- Develop validation strategy for manufacturing process for new drug products or for post-approval changes. Routinely evaluate process performance to ensure all Xellia products are monitored and maintained in a validated state- Develop, review and implement Xellia’s global standards, guidelines and SOPs on manufacturing process validation, equipment qualification, Product lifecycle management and Quality to ensure GMP compliance and promote standardization

Zagreb, Grad Zagreb, Croatia

- Responsible for parts of technology transfer and/or analytical methods transfer;- Identify needs for new laboratory equipment;- R&D audits and due diligences of potential external collaborators;- Assessment and design of new R&D and analytical/pharmaceutical processes- Formulation and process development for finished dosage form and combination products- Assess technological suitability/fit of a potential manufacturing site for production of specific FDF product- R&D audits and due diligences of potential external collaborators- Assessment and design of new R&D and analytical/pharmaceutical processes- Responsible for formulation R&D activities and its results, and manage scientists/technicians in the laboratory work- Risk assessments for manufacturing process and combination products

Zagreb

- Research and development activities in pharmaceutical technology and analytical development with the aim to define final bioequivalent formulation and manufacturing process;- Preparation of all FDF R&D related documents needed for regulatory submissions, including responding to questions from authorities and customers;- Participation in the technology transfer process- Developed/validated analytical test methods, specification- Participation in technology transfer process, analytical method transfers and verification- Responsible for introduction of new analytical techniques, as well as new equipment- Qualification and maintenance of the finished dosage analytical laboratory

Croatia

Court interpreter nominated by the tribunal in Rijeka for the french language.

Zagreb

Translations of documents, consecutive translations french <->croatian, french <-> english

Zagreb

Management of a water treatment plant for landfill leachate water. Design of water treatment processes.

Maintenance of network and computer equipement in the french school of Zagreb.

Zagreb

environmental impact assessment, air pollution measurements (ambient and emission), environmental quality assessments, waste management planning, IT administrator, ISO 17025 Quality manager

Held classes in computer technologies and science. Website and IT management.

Phd In Chemical Engineering, Reaction Engineering

Master, Chemical Engineering

Activities and Societies: Student assistant in several subjects : General and inorganic chemistry, Chemical engineering thermodynamics.