For one of our clients in Switzerland (Basel), we are looking for an experienced Scientific Technical Leader for a long term project.
If you have an advanced scientific degree, and industry experience in the development of pharmaceutical formulations, then you are the ideal candidate for this role!
Don't hesitate, and apply today!
Create and drive with scientific & technological excellence the formulation development and manufacturing work for your assigned project (such as formulation- and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation) in close collaboration with operations, analytics, particle engineering and biopharmaceutical experts, QA and the project DPPL.
- Be accountable for all formulation and manufacturing process deliverables incl. scientific documentation and excipient qualification for all assigned projects.
- Create, own and update formulation project plans aligned with the control strategy being in line with the overall DP and TRD project plan, Development Manuals, SOPs and PHAD strategy. Clearly define roles and responsibilities as well as deliverables for your assigned project(s). Ensure that your plan and strategy is communicated timely to and understood by all involved colleagues from operations such as FEs and FSs.
- Drive DP development and supply activities with scientific and technological excellence.
- Represent formulation development in the Drug Product subteam.
- Closely collaborate with your Drug Product subteam team members understand, identify and manage with them together critical aspects around DS, DP, packaging and analytics.
- Drive regular exchange with Biopharmaceutics Experts to understand critical factors for absorption and DP-performance and build this understanding into your development strategy.
- Drive regular exchange with internal SMEs such as the Technology Focus Groups covering pharmaceutical unit operations of your Drug Product and build their guidance into your development strategy.
- Author Create documents (such as CSF, FMI development reports) and Supply documents (MIs, PHAD application sheets) to allow timely start of development trials, process transfers and supply activities.
- Contribute to the generation of filing dossiers, answer DP related questions in inspections and support Health Authority requests.
- Support the DPPL during the EP/LP project review process (CheckPoints) and at relevant governance boards.
- Take diligently accountability for handling timely Change Requests and for deviation handling via AQWA & TQW, and support the creation of SAP-information systems.
- Take accountability for the preparation and representation of project/product-related aspects during internal and health authority inspections (e.g. batch production records, project/product-related change requests and deviations, etc.
- Advanced degree in scientific or relevant discipline (PhD or equivalent)
- Fluent in English (oral & written). German and/or French desired.
- 5 - 10 years of successful industry experience in the development of pharmaceutical formulations. (ideally oral solid dosage forms), solid understanding of QbD and biopharmaceutics).
- Interdisciplinary thinking and interest in collaboration with other functions.
- Excellent scientific skills
- Excellent knowledge of laboratory and/or technical tools (e.g. QbD, statistical software, PAT).
- Broad and profound understanding of formulation development activities.
- Successfully demonstrated track record of creativity and problem solving in projects.
- Strong knowledge of relevant GLP, GMP regulations and policies.
- Strong presentation skills and scientific/technical writing skills.
- Good project management skills.
- Good communication skills, organizational, planning and negotiation skills.
- Good coaching skills.
015 21 11 04