Senior Scientist Drug Product Manufacturing
Senior Scientist Drug Product Manufacturing
Ipsen Pharma
Dreux, France
In respect to Good Manufacturing Practices and as part of the development of Drug Products, the Senior Scientist Drug Product Manufacturing:
- ensures the realization of all clinical manufacturing operations;
- 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.
This entails to be strongly involved in the continuous improvement process and knowledge management relating to the development of NCEs and Life Cycle Management of commercial products within the DPD department.
Drug Product Manufacturing responsibilities
- Ensure the implementation and monitoring of the manufacturing and primary packaging of clinical batches of semi-finished products (oral and injectable forms), i.e. batches intended to support clinical studies (Phase I to Phase III);
- Within the framework of outsourced activities, ensure the follow-up of subcontractors: set up of contracts/QTAs, organization of regular meetings, performance control through KPIs, budget follow-up;
- In collaboration with the Operational Quality Assurance team, review batch records and instructions of clinical batches;
- Manage in collaboration with the Product Quality Assurance and Regulatory team the quality events using the problem-solving tools;
- Ensure the on-time availability of the documents required for his/her activities, i.e. protocols and reports;
- Present the results and progress of projects under his/her responsibility at internal technical meetings;
- Provide support to the Formulation and Process team for the development of new formulations, transfer and scale-up of manufacturing processes in order to prepare the first clinical batches;
- Develop and optimize the department's interfaces with the Analytical Development team for the analysis of clinical batches;
- Develop and optimize the department's interfaces with Global Supply Chain Management team for the definition and delivery of patient kits in different countries;
- Represent the Drug Product Mnaufacturing function in CMC project meetings and ensure full alignment and adequate communication with the CMC lead;
- Coordinate and lead internal meetings involving relevant CMC functions for clinical campaign preparation and follow-up;
- Ensure regulatory surveillance related to its activities (guidelines, GMP, Annex 13, Annex 1);
- Develop/maintain a network of efficient subcontractors to ensure its activities;
- Ensure the application of the Quality, Health, Safety and Environment (HSE) rules of the company and the site, identify potential deviations in the department and ensure the implementation of the necessary corrective actions.
Continuous improvement:
- Contribute to continuous improvement projects within the Formulation, Process Dev and Clinical Supply Department and/or wider Pharmaceutical Development;
- Be a promoter of continuous improvement processes and to guarantee the method.
QEEHS Responsibilities:
- Respect the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
CSR Responsibilities:
- Apply and proactively contribute to actions for CSR development according to Ipsen guidelines.
Education/Certifications
- Pharmacist, engineer, degree in science or equivalent, ideally with a PhD in science.
Experience
- 3-5 years’ experience in an equivalent job in the Pharmaceutical Industry with a significant international exposure.
Languages
- Fluent in English to effectively interface with English-speaking subcontractors.
Technical skills
- 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.
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