Senior Product Development Manager
Would you like to join us in a challenging position as a Product Development Manager in Clinical Manufacturing & CMO/CRO Management?
Clinical Manufacturing & CMO/CRO Management is focused on CMC development activities of peptide and protein product development for projects at all stages of R&D. We are an experienced and diverse team of generalists and scientists building strong scientific business relationships with external stakeholders to deliver excellent development opportunities to our projects. We are now growing and seeking a highly motivated and energetic candidate with a strong background within peptide and protein formulation to join our development team.
As part of Clinical Manufacturing & CMO/CRO Management your essential tasks will be:
- Establish strategies that meet project and regulatory requirements, in collaboration with the cross functional CMC team
- Identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness In collaboration with the Procurement Manager
- Develop and maintain project management skills and scientific knowledge to oversee formulation and process development activities effectively
- Liaise with service providers on a regular basis to monitor progress , as well as resolve technical, quality and resource issues smoothly
- Review and manage technical data and documentation to ensure timely action, high scientific quality and efficient retrieval
- Initiate/introduce new scientific know-how and keep an updated scientific and regulatory knowledge in the areas of formulation and process development of oral and nasal peptide delivery formulations
We expect the ideal candidate to have:
- Minimum a M.Sc. in pharmaceutical sciences, chemical engineering or equivalent education preferable a Ph.D.
- Minimum 10 years experience in pharmaceutical industry
- Proven scientific skills in peptide formulation development, preferably oral liquid and solid dosage forms
- Proven scientific skills in nasal drug product development is an asset
- Proven project coordination/ management skills with both internal and external stakeholders
- Substantial experience of managing international business relationships with external service providers
- Ability to critically analyse data, apply problem solving methodologies and make sound decisions and recommendations
- Quality and continuous improvement mindset
- Experience with GMP and regulatory guidelines and writing regulatory documentation
- Excellent communication skills and fluent in English, both spoken and written
- Keen on working in an international multicultural corporate environment
For additional information, please contact Director Christine Germann direct phone +45 28 78 79 04. Send your application and CV in English as soon as possible and no later than 30th Apr 2017 as we will review incoming applications on an on-going basis.