Pharmaceutical Development

vor 4 Wochen

Deutschland gloor&lang AG' Vollzeit

CDMO Management for Steriles 12 months contract |
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. 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
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
PhD, MSc. 5 years of experience in development and manufacturing
~ Experience with sterile/parenteral drug product (bio)pharmaceuticals
~ Experience in project management and/or collaboration with CMO/CRO
~ 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.

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