Pharmaceutical Development

--- | CDMO Management for Steriles 12 months contract | Our customer is an innovative commercial stage Biopharmaceutical company in Basel. Various exciting investments in R&D activities will increase project volume significantly. Within the department of Technical Operations, the small team of Formulation Development will need further reinforcement of an experienced professional. The team is mainly handling transfer activities to CDMOs for projects in clinical phase I to III. department within the Supply Chain Team is in charge of transferring new products to commerical manufacturing partners. Your tasks: * Responsible for pharmaceutical development and manufacturing of drug products

• Assure clinical stage supplies in compliance with GMP and regulatory requirements
• Identify, evaluate and select appropriate pharmaceutical development and manufacturing organizations
• Contribute to implementation of contracts and technical agreements
• Select appropriate formulations and formulation technologies
• Oversee, manage and drive the outsourced pharmaceutical development, transfer and manufacturing activities
• Proactively track project progress and critical path activities; review project risks
• Develop formulation and process development strategies in alignment with the CMC team
• Review and contribute to protocols for development, scale up manufacture, process validation
• Compile, review and contribute to reports and evaluate data provided by the CDMO
• Review batch documentation, assess deviations and contribute to batch release activities

Your profile: * PhD, MSc. Pharmaceutical Sciences or equivalent education

• 5 years of experience in development and manufacturing

• Experience with sterile/parenteral drug product (bio)pharmaceuticals
• Experience with biological compounds and biological drug product processes preferred.
• Experience in project management and/or collaboration with CMO/CRO
• Experience in establishing regulatory documents (Drug Product part of IMPD/INDs, CTDs)

This interactive position requires excellent communication skills and the ability to present convincing arguments on behalf of the project team to the Senior Management. You are used to utilize a variety of problem solving methods as well as to interface at a senior level with third parties and development partners. Travelling in the regions EU/USA shall represent up to 10-15% of your time. Mastery of the necessary “soft skills” to achieve high-performance teamwork for geographically dispersed partners is a key challenge of the position. |