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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.  

Oncoteq AG is founded and seeded by Cureteq AG and headquartered in Cham.

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.

For applications please contact: volker.menschik@cureteq.com