Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities. In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery. EyeD Pharma and UniD Manufacturing lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.
To support its development, UniD Manufacturing is hiring a Pharmaceutical Development Leader
Your responsibilities :
The Pharmaceutical Development Leader supports the development of pharmaceutical product and associated manufacturing processes, to comply with all quality/regulatory/customer requirements. It covers all the development steps from the formulation screening to the definition of the monitoring plans of the commercial productions.
- Documenting all the customer requirements and their translation into product/process development objectives;
- Supporting the formulation, process development and control strategies (design, verification, monitoring) for each step of the product life cycle (from feasibility to commercial productions);
- Designing, planning, executing, and documenting development studies to support product/process development in accordance with department strategy and customer requirements (cost/quality/timing);
- Ensuring coordination and follow-up of development activities with the project manager and the other departments (eg. samples production execution, data generation…) as required by protocols/plans;
- Contributing to product/process risk management activities according to quality system and appropriate standards;
- Participating in the identification of raw materials, process technologies, suppliers and subcontractors for the product/process development;
- Participating in the investigation/impact assessment of any changes/deviations occurring on raw materials, products and the manufacturing process (CMA, CQA and CPP);
- Participating in the monitoring the new process/product/products trends and evaluating their potential interest;
- Ensuring critical data review and data integrity compliance with GxP and standards requirements;
- Participating in meeting with customers;
Your profile :
- Master in Sciences, Engineering or Pharmacy
- At least 3 years in GMP manufacturing environment
- Good knowledge and experience in medicinal and/or combined products pharmaceutical development and risk management (ICH Q8, ICH Q9, ISO 13485)
- Experience in development of drug delivery system based on polymer technology is an asset
- Excellent technical writing skills
- Data driven, with good statistical competences
- Fluent in English and French
- Excellent organization and management skills
- Solution driven & results oriented
- Team player, Integrity, Caring
- Proactive and autonomous.
EyeD Pharma offer :
- A permanent position in an innovative and dynamic and fast growing company;
- Full time;
Please send your CV and cover letter in English to : firstname.lastname@example.org.