- Lead all formulation, process and drug product development activities according to the quality target product profile and supply aspects of their projects for clinical and pre-clinical trials in coordination with the CMC and wider project teams in line with patients’ needs.
- Define and implement Drug Product development and manufacturing strategies accordingly.
- Act as the main point of contact, managing, challenging and leading activities with external partners, including supplier selection, negotiating offers and contracts.
- Lead regulatory and control strategies for semi-finished products in line with Quality by Design principles, taking into consideration the status of the project, assessing technical risks, and ensuring their mitigation.
- Support the redaction of regulatory affairs documentation sections related to your area of expertise.
- Propose and implement innovative formulation strategies based on a deep understanding of compound developability, drug delivery, innovative processes and technology providers.
- Establish and implement drug product development strategies (including Life Cycle Management).
- Integrate, in the design of technical strategies, issues related to Intellectual property and freedom to operate.
- Prepare and review key documents (development reports, protocols, batch records, etc.).
- A Master’s degree in a relevant scientific discipline (pharmaceutical engineering, etc), pharmacist or equivalent.
- At least 5 years of industrial experience, working in hands-on formulation /drug product development roles in the pharmaceutical industry.
- Proven expertise in the field of pharmaceutical product development for oral solid dosages and, ideally, injectable products as well as supporting regulatory and quality guidelines.
- Field experience in pharmaceutical product development and manufacturing at laboratory and pilot scales. Strong technical knowledge to design and manage process development and scale up studies.
- Experience in process development with Quality by Design approach.
- Experience in managing contract development and manufacturing organizations (CDMOs).
- Knowledge of radiopharmaceutical or biological drug development is a plus.
- Experience and the ability to work as part of a team and effectively prioritize tasks.
- High natural motivation in dealing with project challenges and leading innovation.
- Consistent, good knowledge of standard IT tools.
- Fluency in the language of English.
|Job Category||TECHNICAL R&D|