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Director Technical Development
This role is responsible for driving the overall CMC activities for the drug candidates under development at Oncoteq AG.
Responsibilities:
- Definition and implementation of the pharmaceutical and chemical development strategy for early phase projects (small molecules and biologics), including formulation, manufacturing, analytical development, technical regulatory and GMP compliance aspects.
- Participation in vendor evaluation and selection processes for technical development activities. Negotiation of relevant contracts with the selected vendors and service providers.
- Drive, oversee and control CMC vendors’ activities, with emphasis on quality of deliverables, timelines, robustness, and cost efficiency, to ensure timely clinical supply of drug products.
- Support CMC and quality related interactions with Regulatory Authorities and provide input / write / review CMC documents and regulatory sections in collaboration with other functions, as required.
- Budgeting and forecasting of CMC activities.
- Performance of due diligence activities related to CMC/quality aspects of in-licensing candidates.
Required background and experience:
- Master’s degree or PhD in Pharmacy, Chemistry or equivalent, with a minimum 10 years of experience in the pharmaceutical industry and a minimum 5 years of experience in the field of Technical Development, concerning drug substance and/or drug product (pharmaceutical/formulation/process/analytical development).
- Profound understanding of general scientific, technical, and quality aspects of the pharmaceutical industry, as well as EU /US technical regulatory requirements.
- High level of English language proficiency.
Required competencies:
- Excellent communication, negotiating, planning and organization skills.
- Capability to balance between high-level strategic perspective and proper attention to detail when a hands-on approach is required.
- Openness and flexibility to adapt to changing scenarios.
- Ability to work independently and collaboratively within a team, as required.
- Strong project and risk management skills.
- Self-motivated, proactive and solution oriented attitude.
- Used to work in an international environment.
Please send applications to: volker.menschik@cureteq.com