Pharmaceutical Development Manager
vor 9 Stunden
Villars-sur-Glâne, CH **Our Company**: CordenPharma is a leading Contract Development Manufacturing (CDMO) partner with approximately 2’000 employees and annual revenues > 500 M€, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives. The CordenPharma site in Fribourg is a site specialized in the manufacturing solid drug products and oral liquids developing and manufacturing for clients worldwide. To strengthen our team in Villars-sur-Glâne we are looking as soon as possible for a **Pharmaceutical Development Manager / Sr. Manager***: **Function description**: At this position, you work within the Product Development and Process Technology department and are responsible for the management, leadership, and supervision of pharmaceutical development - and transfer-projects in line with CordenPharma procedures and according to current international guidelines. Your main activities are: **Main activities**: - Formulation and packaging development as well as elaboration of suitable manufacturing processes of liquid and solid dosage forms. - Definition of target product profiles and justifying product specifications. - Author and review test and development reports. - Edit and release scale-up, manufacturing validation plans and reports. - Prepare and review manufacturing instructions, risk analysis and parts of regulatory submissions to support drug product filings. - Technical and operational management of manufacturing transfers (out - or back-sourcing). - Evaluation of new raw materials or raw material changes and assessing the impact on the drug product. - Contribute as an expert to the compilation of technical documentation for the submission of new products or variations to the authorities. - Seasoned and familiar with working as a member in multicultural, virtual, and local project teams. - Experienced in using QbD-based developments and up-scales including the evaluation and definition of CPPs, CQAs and CMAs. - Independent technical and operational management of drug-product-development and life-cycle-management projects within the agreed budget, timelines, and milestones. - Active tracking of trends and changes in the pharmaceutical technology and manufacturing ecosystem to stay up-to-date with new technologies and to integrate them into the site. - Represent the product development group at site-level, when required. **Desired Skills and Experience**: - University Degree (M.Sc., Ph.D.) in pharmaceutical sciences or similar working experience. - At least 5 years of experience in similar roles within the pharmaceutical industry. - Expert theoretical and applied knowledge of pharmaceutical technologies for solid and liquid drug products and knowledgeable of current GMP standards. - Fluent in English and in French both orally and in writing. Knowledge of German is an asset. - Experienced in managing, supervising and leading projects and people - both directly and collaterally. You are an assertive, conscientiously working, and well-organized personality with a strong analytical mind-set and quality-oriented attitude. Thanks to your good communication skills, you interact easily with other departments. You are able to do your tasks autonomously with mínimal supervision and you are willing to develop yourself as a leader to guide and coach people. **What we offer**: We offer a permanent contract, a competitive salary package and varied and motivating responsibilities. **Interested?**:
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